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 Gl625-w.
| Device ID | K971235 | 
| 510k Number | K971235 | 
| Device Name: | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W | 
| Classification | Oximeter | 
| 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 | DQA | 
| CFR Regulation Number | 870.2700 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1997-04-02 | 
| Decision Date | 1997-06-05 |