The following data is part of a premarket notification filed by Biotrine Corp. with the FDA for Flo-cor I.
| Device ID | K812825 |
| 510k Number | K812825 |
| Device Name: | FLO-COR I |
| Classification | Pneumotachometer |
| Applicant | BIOTRINE CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JAX |
| CFR Regulation Number | 868.2550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-08 |
| Decision Date | 1981-10-26 |