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 Bed, Pediatric Open Hospital
510(k) Number K881019
Device Name BABYROCKER
Applicant
Cinventa AB
Utlandagatan 24
S-412 80 Goteborg
Sweden,  SE
Applicant Contact G ROSEN
Correspondent
Cinventa AB
Utlandagatan 24
S-412 80 Goteborg
Sweden,  SE
Correspondent Contact G ROSEN
Regulation Number880.5140
Classification Product Code
FMS  
Date Received03/10/1988
Decision Date 06/07/1988
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
-
-