K892524 is an FDA 510(k) clearance for the VITALOGRAPH-BREATHCO MONITOR. This device is classified as a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II - Special Controls, product code CCJ).
Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on May 5, 1989, 24 days after receiving the submission on April 11, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1430.
| 510(k) Number | K892524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1989 |
| Decision Date | May 05, 1989 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | CCJ - Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1430 |