The following data is part of a premarket notification filed by Enviracaire Corp. with the FDA for Enviracaire Model Ev-1.
| Device ID | K872359 |
| 510k Number | K872359 |
| Device Name: | ENVIRACAIRE MODEL EV-1 |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | ENVIRACAIRE CORP. 747 BOWMAN AVE. Hagerstown, MD 21740 |
| Contact | George B Davis |
| Correspondent | George B Davis ENVIRACAIRE CORP. 747 BOWMAN AVE. Hagerstown, MD 21740 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-18 |
| Decision Date | 1987-12-07 |