The following data is part of a premarket notification filed by Physio-dyne with the FDA for Physio-dyne Easi - Lab.
| Device ID | K922660 |
| 510k Number | K922660 |
| Device Name: | PHYSIO-DYNE EASI - LAB |
| Classification | Computer, Oxygen-uptake |
| Applicant | PHYSIO-DYNE 35 JEANETTE DR. Massapequa, NY 11758 |
| Contact | Donald B Falk |
| Correspondent | Donald B Falk PHYSIO-DYNE 35 JEANETTE DR. Massapequa, NY 11758 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-03 |
| Decision Date | 1993-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B9671504000 | K922660 | 000 |