K982550 is an FDA 510(k) clearance for the BROWSER (EVENT SOFTWARE) MODEL # 4500E. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on October 5, 1998, 75 days after receiving the submission on July 22, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K982550 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | July 22, 1998 |
| Decision Date | October 05, 1998 |
| Days to Decision | 75 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 |