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 K851439
Device Name MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
Applicant
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Applicant Contact OTMAR H SACKERLOTSK
Correspondent
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Correspondent Contact OTMAR H SACKERLOTSK
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/10/1985
Decision Date 07/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-