Submission Details
| 510(k) Number | K832767 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 1983 |
| Decision Date | November 03, 1983 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K832767 is an FDA 510(k) clearance for the ADVANTAGE #1700, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983, 79 days after receiving the submission on August 16, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K832767 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 1983 |
| Decision Date | November 03, 1983 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1400 |