K974200 is an FDA 510(k) clearance for the ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM. This device is classified as a Calculator, Pulmonary Function Interpretor (diagnostic) (Class II - Special Controls, product code BZM).
Submitted by Orca Diagnostics Corp. (Los Altos, US). The FDA issued a Cleared decision on July 21, 1998, 253 days after receiving the submission on November 10, 1997.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1900.
| 510(k) Number | K974200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1997 |
| Decision Date | July 21, 1998 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZM — Calculator, Pulmonary Function Interpretor (diagnostic) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1900 |