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, Diagnostic
510(k) Number K030464
Device Name GEM, MODEL 004110
Applicant
Collins Medical, Inc.
220 Wood Rd.
Braintree,  MA  02184 -2408
Applicant Contact DONALD HENTON
Correspondent
Collins Medical, Inc.
220 Wood Rd.
Braintree,  MA  02184 -2408
Correspondent Contact DONALD HENTON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/12/2003
Decision Date 03/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-