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 Chamber, Hyperbaric
510(k) Number K862198
Device Name SIGMA II - DUAL PLACE HYPERBARIC CHAMBER
Applicant
PERRY BAROMEDICAL SERVICES
C/O MEDICAL DEVICE INSPECTION
CO., 55 NORTHERN BLVD. STE 205
GREAT NECK,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
PERRY BAROMEDICAL SERVICES
C/O MEDICAL DEVICE INSPECTION
CO., 55 NORTHERN BLVD. STE 205
GREAT NECK,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number868.5470
Classification Product Code
CBF  
Date Received06/09/1986
Decision Date 11/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-