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 Spirometer, Therapeutic (Incentive)
510(k) Number K991300
Device Name BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
Applicant
Dhd Healthcare Corp.
One Madison St.
Wampsville,  NY  13163
Applicant Contact LARRY WEINSTEIN
Correspondent
Dhd Healthcare Corp.
One Madison St.
Wampsville,  NY  13163
Correspondent Contact LARRY WEINSTEIN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received04/16/1999
Decision Date 07/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-