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 Calculator, Pulmonary Function Interpretor (Diagnostic)
510(k) Number K874902
Device Name SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY
Applicant
Gomi Medical Instruments
740 Fawn Dr.
San Anselmo,  CA  94960
Applicant Contact GOMIDAS JIBELIAN
Correspondent
Gomi Medical Instruments
740 Fawn Dr.
San Anselmo,  CA  94960
Correspondent Contact GOMIDAS JIBELIAN
Regulation Number868.1900
Classification Product Code
BZM  
Date Received12/01/1987
Decision Date 06/07/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-