K771532 is an FDA 510(k) clearance for the SPIROMETEO & LUNG EXERCISER, 4601. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by Boehringer Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 26, 1977, 16 days after receiving the submission on August 10, 1977.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K771532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1977 |
| Decision Date | August 26, 1977 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BWF — Spirometer, Therapeutic (incentive) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5690 |