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 monitor, oxygen, cutaneous, for infant not under gas anesthesia
510(k) Number K893133
Device Name HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
Applicant
MENNEN MEDICAL, INC.
10123 MAIN ST.
CLARENCE,  NY  14031
Applicant Contact RICHARD G WHITEHEAD
Correspondent
MENNEN MEDICAL, INC.
10123 MAIN ST.
CLARENCE,  NY  14031
Correspondent Contact RICHARD G WHITEHEAD
Regulation Number868.2500
Classification Product Code
KLK  
Date Received04/25/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-