K863866 is an FDA 510(k) clearance for the RESPIRADYNE II(TM). This device is classified as a Spirometer, Monitoring (w/wo Alarm) (Class II - Special Controls, product code BZK).
Submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on January 28, 1987, 117 days after receiving the submission on October 3, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1850.
| 510(k) Number | K863866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1986 |
| Decision Date | January 28, 1987 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZK — Spirometer, Monitoring (w/wo Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1850 |