The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for O-pep.
| Device ID | K150044 |
| 510k Number | K150044 |
| Device Name: | O-PEP |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | PARI RESPIRATORY EQUIPMENT, INC. 2412 PARI Way Midlothian, VA 23112 |
| Contact | Michael Judge |
| Correspondent | Michael Judge PARI RESPIRATORY EQUIPMENT, INC. 2412 PARI Way Midlothian, VA 23112 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-12 |
| Decision Date | 2016-05-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229100010 | K150044 | 000 |