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 K881402
Device Name 629V SPIROMETER, PULMONARY FUNCTION ANALYZER
Applicant
AMERICAN ELECTROMEDICS CORP.
13 SAGAMORE PARK RD.
HUDSON,  NH  03051
Applicant Contact T. M GLEASON
Correspondent
AMERICAN ELECTROMEDICS CORP.
13 SAGAMORE PARK RD.
HUDSON,  NH  03051
Correspondent Contact T. M GLEASON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/04/1988
Decision Date 09/26/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-