The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Sherwood Ventilatory Muscle Trainer.
| Device ID | K802165 |
| 510k Number | K802165 |
| Device Name: | SHERWOOD VENTILATORY MUSCLE TRAINER |
| Classification | Device, Rebreathing |
| Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYW |
| CFR Regulation Number | 868.5675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-08 |
| Decision Date | 1980-09-26 |