• 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, airway pressure (includes gauge and/or alarm)
510(k) Number K961318
Device Name 1ST RESPONSE DISPOSABLE MANOMETER
Applicant
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Applicant Contact AVIA TONEY, RAC
Correspondent
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS,  FL  33905
Correspondent Contact AVIA TONEY, RAC
Regulation Number868.2600
Classification Product Code
CAP  
Date Received04/05/1996
Decision Date 12/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-