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 Warmer, Infant Radiant
510(k) Number K934677
Device Name U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE
Applicant
U.S. Medical Corp.
12 Scovil Rd.
Higgaum,  CT  06441
Applicant Contact BRUCE E DODSON
Correspondent
U.S. Medical Corp.
12 Scovil Rd.
Higgaum,  CT  06441
Correspondent Contact BRUCE E DODSON
Regulation Number880.5130
Classification Product Code
FMT  
Date Received09/28/1993
Decision Date 07/05/1994
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
-
-