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, powered (resuscitator)
510(k) Number K861272
Device Name IMPACT MODELS 701, 702 AND 703
Applicant
IMPACT INSTRUMENTATION, INC.
P.O. BOX 412
BOGOTA,  NJ  07603
Applicant Contact LESLIE H SHERMAN
Correspondent
IMPACT INSTRUMENTATION, INC.
P.O. BOX 412
BOGOTA,  NJ  07603
Correspondent Contact LESLIE H SHERMAN
Regulation Number868.5925
Classification Product Code
BTL  
Date Received04/04/1986
Decision Date 05/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-