Submission Details
| 510(k) Number | K831780 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K831780 is an FDA 510(k) clearance for the METABOLIC EXERCISE TESTING SYSTEM, a Computer, Oxygen-uptake (Class II — Special Controls, product code BZL), submitted by Warren E. Collins, Inc. (Walker, US). The FDA issued a Cleared decision on September 12, 1983, 102 days after receiving the submission on June 2, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1730.
| 510(k) Number | K831780 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 1983 |
| Decision Date | September 12, 1983 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZL — Computer, Oxygen-uptake |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1730 |