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 K012368
Device Name AEROPEP
Applicant
TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON, ONTARIO,  CA N5V 5G4
Applicant Contact TOM HOLBROOK
Correspondent
TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON, ONTARIO,  CA N5V 5G4
Correspondent Contact TOM HOLBROOK
Regulation Number868.5690
Classification Product Code
BWF  
Date Received07/26/2001
Decision Date 02/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-