K853434 is an FDA 510(k) clearance for the ERGO-PNEUMOTEST. This device is classified as a Computer, Oxygen-uptake (Class II - Special Controls, product code BZL).
Submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on February 5, 1986, 174 days after receiving the submission on August 15, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1730.
| 510(k) Number | K853434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 1985 |
| Decision Date | February 05, 1986 |
| Days to Decision | 174 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 |