The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Manufacturing Co. Rechargeable Battery Part Number M212.
| Device ID | K972084 |
| 510k Number | K972084 |
| Device Name: | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 |
| Classification | Monitor, Electric For Gravity Flow Infusion Systems |
| Applicant | ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
| Contact | Ken Heimendinger |
| Correspondent | Ken Heimendinger ALEXANDER MFG. CO. 1511 S GARFIELD PL Mason City, IA 50401 |
| Product Code | FLN |
| CFR Regulation Number | 880.2420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-04 |
| Decision Date | 1997-07-03 |