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 Generator, Oxygen, Portable
510(k) Number K880044
Device Name OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8
Applicant
OXYGEN ENRICHMENT COMPANY, LTD.
1900 MAXON RD.
P.O. BOX 1025
SCHENECTADY,  NY  12308
Applicant Contact JAMES C HUSSEY
Correspondent
OXYGEN ENRICHMENT COMPANY, LTD.
1900 MAXON RD.
P.O. BOX 1025
SCHENECTADY,  NY  12308
Correspondent Contact JAMES C HUSSEY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/06/1988
Decision Date 03/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-