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 K852677
Device Name MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM
Applicant
ALPHA TECHNOLOGIES, INC.
23142-A ALCALDE
LAGUNA HILLS,  CA  92653
Applicant Contact DENNIS A NEFF
Correspondent
ALPHA TECHNOLOGIES, INC.
23142-A ALCALDE
LAGUNA HILLS,  CA  92653
Correspondent Contact DENNIS A NEFF
Regulation Number868.1840
Classification Product Code
BZG  
Date Received06/24/1985
Decision Date 07/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-