K873521 is an FDA 510(k) clearance for the BRONCHODILATOR TEE - 9056 SERIES. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 2, 1988, 183 days after receiving the submission on September 1, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K873521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1987 |
| Decision Date | March 02, 1988 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |