Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K182401
Device Name B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
Applicant
AmZetta Technologies Private Limited
Kumaran Nagar, Semmanchery, Off Rajiv Gandhi Salai (OMR)
Chennai,  IN 600 119
Applicant Contact Sridharan Mani
Correspondent
AmZetta Technologies Private Limited
Kumaran Nagar, Semmanchery, Off Rajiv Gandhi Salai (OMR)
Chennai,  IN 600 119
Correspondent Contact Sridharan Mani
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DXN   FLL  
Date Received09/04/2018
Decision Date 08/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-