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 ventilator, emergency, manual (resuscitator)
510(k) Number K981307
Device Name INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
Applicant
INTERNATIONAL RESPIRATORY SYSTEMS, INC.
PO BOX 4341
CROFTON,  MD  21114
Applicant Contact E.J. Smith
Correspondent
INTERNATIONAL RESPIRATORY SYSTEMS, INC.
PO BOX 4341
CROFTON,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number868.5915
Classification Product Code
BTM  
Date Received04/10/1998
Decision Date 07/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-