The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for Pari Pep S.
| Device ID | K090829 |
| 510k Number | K090829 |
| Device Name: | PARI PEP S |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Contact | Michael Judge |
| Correspondent | Michael Judge PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. 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 | 2009-03-26 |
| Decision Date | 2009-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229100003 | K090829 | 000 |