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, Continuous, Facility Use
510(k) Number K873549
Device Name PEDIATRIC BELLOWS
Applicant
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Applicant Contact PERK CROOK
Correspondent
DRAEGER MEDICAL, INC.
148 B. QUARRY RD.
TELFORD,  PA  18969
Correspondent Contact PERK CROOK
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/31/1987
Decision Date 10/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-