The following data is part of a premarket notification filed by Innovative Medical Systems, Inc. with the FDA for Positive Airway Pressure System.
| Device ID | K933184 |
| 510k Number | K933184 |
| Device Name: | POSITIVE AIRWAY PRESSURE SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | INNOVATIVE MEDICAL SYSTEMS, INC. 1 MERRILL DR. Hampton, NH 03842 |
| Contact | Fran White |
| Correspondent | Fran White INNOVATIVE MEDICAL SYSTEMS, INC. 1 MERRILL DR. Hampton, NH 03842 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-30 |
| Decision Date | 1994-11-28 |