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 K780458
Device Name TRANSCUTANEOUS OXYGEN PERFUSION MONITOR
Applicant
Narco Air-Shields
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Narco Air-Shields
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.2500
Classification Product Code
KLK  
Date Received03/23/1978
Decision Date 10/10/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-