K981728 is an FDA 510(k) clearance for the ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Alexander Mfg. Co. (Mason City, US). The FDA issued a Cleared decision on June 26, 1998, 42 days after receiving the submission on May 15, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K981728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | May 15, 1998 |
| Decision Date | June 26, 1998 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZQ — Monitor, Breathing Frequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |