The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Rechargeable Battery Part Number Gl825-200.
| Device ID | K974061 |
| 510k Number | K974061 |
| Device Name: | RECHARGEABLE BATTERY PART NUMBER GL825-200 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-27 |
| Decision Date | 1998-01-16 |