The following data is part of a premarket notification filed by Orca Diagnostics Corp. with the FDA for Orca Cardiopulmonary Exercise Testing System.
| Device ID | K974200 |
| 510k Number | K974200 |
| Device Name: | ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | ORCA DIAGNOSTICS CORP. P.O. BOX 1951 Los Altos, CA 94019 |
| Contact | Sheila W Pickering |
| Correspondent | Sheila W Pickering ORCA DIAGNOSTICS CORP. P.O. BOX 1951 Los Altos, CA 94019 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-10 |
| Decision Date | 1998-07-21 |
| Summary: | summary |