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 Mattress, Air Flotation, Alternating Pressure
510(k) Number K952092
Device Name ERGOMAT 8000 SYSTEM
Applicant
ERGO-AIR, INC.
30 HOOPER ST.
WESTBURY,  NY  11590
Applicant Contact PETER W LINLEY
Correspondent
ERGO-AIR, INC.
30 HOOPER ST.
WESTBURY,  NY  11590
Correspondent Contact PETER W LINLEY
Regulation Number880.5550
Classification Product Code
FNM  
Date Received05/03/1995
Decision Date 07/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-