The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Mfg. Rechargeable Battery (model M3).
| Device ID | K970787 |
| 510k Number | K970787 |
| Device Name: | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3) |
| Classification | Electrocardiograph |
| Applicant | ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
| Contact | Stacey Hippen |
| Correspondent | Stacey Hippen ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-05-14 |