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 K881207
Device Name RES-Q 1, 2, 3, 4 AND 5
Applicant
Nova-Ventrx
4309 Regency Dr.
Wheeling,  IL  60025
Applicant Contact BERNARD R PALUCH
Correspondent
Nova-Ventrx
4309 Regency Dr.
Wheeling,  IL  60025
Correspondent Contact BERNARD R PALUCH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/21/1988
Decision Date 08/15/1988
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
-
-