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 K090829
Device Name PARI PEP S
Applicant
PARI RESPIRATORY EQUIPMENT, INC.
2943 OAKLAKE BLVD.
MIDLOTHIAN,  VA  23112
Applicant Contact MICHAEL JUDGE
Correspondent
PARI RESPIRATORY EQUIPMENT, INC.
2943 OAKLAKE BLVD.
MIDLOTHIAN,  VA  23112
Correspondent Contact MICHAEL JUDGE
Regulation Number868.5690
Classification Product Code
BWF  
Date Received03/26/2009
Decision Date 07/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-