K873039 is an FDA 510(k) clearance for the MODEL 820 TOP=TRAK. This device is classified as a Chair, Posture, For Cardiac And Pulmonary Treatment (Class I - General Controls, product code BYN).
Submitted by Sierra Laboratories, Inc. (Carmel Valley, US). The FDA issued a Cleared decision on February 11, 1988, 191 days after receiving the submission on August 4, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5365.
| 510(k) Number | K873039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 1987 |
| Decision Date | February 11, 1988 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYN — Chair, Posture, For Cardiac And Pulmonary Treatment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5365 |