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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 3-132: ISO 27185 First edition 2012-02-15, cardiac rhythm management devices - symbols to be used with cardiac rhythm management device labels, and information to be supplied - general requirements. (Cardiovascular)

Date of Standard: 2012. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Cardiac rhythm management devices
Processes Affected:
All premarket and postmarket processes
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.1750 Generator, Pulse, Pacemaker, External Programmable Class 2 JOQ
§870.3600 Pulse Generator, External Pacemaker, Dual-Chamber Class 3 OVJ
§870.3600 Pulse-Generator, Pacemaker, External Class 3 DTE
Unclassified Pulse-Generator, Single Chamber, Single Class 3 LWW
§870.3610 Implantable Pacemaker Pulse-Generator Class 3 DXY
§870.3620 Pacemaker Lead Adaptor Class 2 DTD
§870.3630 Analyzer, Pacemaker Generator Function Class 2 DTC
Unclassified Device, Removal, Pacemaker Electrode, Percutaneous Class 3 MFA
Unclassified System, Esophageal Pacing Class 3 LPA
§870.3680 Electrode, Pacemaker, Temporary Class 2 LDF
§870.3680 Electrode, Pacing And Cardioversion, Temporary, Epicardial Class 2 NHW
§870.3680 Permanent Pacemaker Electrode Class 3 DTB
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt) Class 3 LWP
Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable Class 3 LWO
§870.3700 Programmer, Pacemaker Class 3 KRG
§870.3720 Tester, Pacemaker Electrode Function Class 2 DTA
Unclassified Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Class 3 NIK
Unclassified Defibrillator, Implantable, Dual-Chamber Class 3 MRM
Unclassified Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Class 3 OJX
Unclassified Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Class 3 NVN
Unclassified Pacemaker/Icd/Crt Non-Implanted Components Class 3 OSR
Unclassified Permanent Defibrillator Electrodes Class 3 NVY
Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Class 3 NKE
Unclassified Pulse Generator, Permanent, Implantable Class 3 NVZ
Unclassified System,Pacing,Temporary,Acute,Internal Atrial Defibrillation Class 3 MTE
Unclassified Wearable Automated External Defibrillator Class 3 MVK
§870.5310 Automated External Defibrillators (Non-Wearable) Class 3 MKJ
§870.5310 Over-The-Counter Automated External Defibrillator Class 3 NSA
Relevant Guidance:
Use of Symbols in Labeling of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff
FDA Technical Contact:
 Mitchell J. Shein
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1316
  Silver Spring MD 20993
  301/796-6363
  email: mitchell.shein@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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