The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Tube, Inhaler Oxygen.
| Device ID | K935582 |
| 510k Number | K935582 |
| Device Name: | TUBE, INHALER OXYGEN |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Contact | Thomas P Dimaio |
| Correspondent | Thomas P Dimaio PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1994-01-14 |