The following data is part of a premarket notification filed by Bearpac Medical with the FDA for Passio Pump Drainage System.
| Device ID | K190292 |
| 510k Number | K190292 |
| Device Name: | Passio Pump Drainage System |
| Classification | Apparatus, Suction, Patient Care |
| Applicant | Bearpac Medical 124 West Point Road Moultonborough, NH 03254 |
| Contact | Jay Zimmerman |
| Correspondent | Jay Zimmerman Bearpac Medical 124 West Point Road Moultonborough, NH 03254 |
| Product Code | DWM |
| CFR Regulation Number | 870.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-11 |
| Decision Date | 2019-07-25 |