The following data is part of a premarket notification filed by Progressive Productions Ltd. with the FDA for Easy Breather Model 100.
| Device ID | K893213 |
| 510k Number | K893213 |
| Device Name: | EASY BREATHER MODEL 100 |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | PROGRESSIVE PRODUCTIONS LTD. 70 ARCHWOOD DR. Mohrsville, PA 19541 |
| Contact | Genevieve M Bogusky |
| Correspondent | Genevieve M Bogusky PROGRESSIVE PRODUCTIONS LTD. 70 ARCHWOOD DR. Mohrsville, PA 19541 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-27 |
| Decision Date | 1989-08-04 |