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 circuit, breathing (w connector, adaptor, y piece)
510(k) Number K935168
Device Name ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS
Applicant
BILL OLSON CORP.
5350 S.W. FIRST LN.
OCALA,  FL  34474
Applicant Contact ROBERT L STONE
Correspondent
BILL OLSON CORP.
5350 S.W. FIRST LN.
OCALA,  FL  34474
Correspondent Contact ROBERT L STONE
Regulation Number868.5240
Classification Product Code
CAI  
Date Received10/27/1993
Decision Date 02/07/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-