K781838 is an FDA 510(k) clearance for the CALCULATOR, WITH CHARGER. This device is classified as a Spirometer, Therapeutic (incentive) (Class II - Special Controls, product code BWF).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1978, 25 days after receiving the submission on October 27, 1978.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5690.
| 510(k) Number | K781838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1978 |
| Decision Date | November 21, 1978 |
| Days to Decision | 25 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 |