510(k) Premarket Notification Database
Device Classification Name |
electrocardiograph
|
510(k) Number | K970787 |
Device Name | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) |
Applicant |
ALEXANDER MFG. CO.
|
1511 s garfield pl |
mason city,
IA
50401 |
|
Contact | stacey hippen |
Regulation Number | 870.2340 |
Classification Product Code |
|
Date Received | 03/04/1997 |
Decision Date | 05/14/1997 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Anesthesiology
|
Statement/Summary/Purged Status |
Statement only
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
|
|