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, monitoring (w/wo alarm)
510(k) Number K972086
Device Name ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
Applicant
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Applicant Contact KEN HEIMENDINGER
Correspondent
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY,  IA  50401
Correspondent Contact KEN HEIMENDINGER
Regulation Number868.1850
Classification Product Code
BZK  
Date Received06/04/1997
Decision Date 08/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-