K831758 is an FDA 510(k) clearance for the FLOW-CALIBRATION MODULE. This device is classified as a Calibrator, Volume, Gas (Class I - General Controls, product code BXW).
Submitted by The Perkin-Elmer Corp. (Walker, US). The FDA issued a Cleared decision on July 19, 1983, 48 days after receiving the submission on June 1, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1870.
| 510(k) Number | K831758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1983 |
| Decision Date | July 19, 1983 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BXW — Calibrator, Volume, Gas |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.1870 |