The following data is part of a premarket notification filed by Alexander Mfg. Co. with the FDA for Alexander Manufacturing Co. Battery Part Number H134.
| Device ID | K981728 |
| 510k Number | K981728 |
| Device Name: | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 |
| Classification | Monitor, Breathing Frequency |
| 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 | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-15 |
| Decision Date | 1998-06-26 |