The following data is part of a premarket notification filed by Pari Holding Co. with the FDA for Pari Pep Therapy System.
| Device ID | K972042 |
| 510k Number | K972042 |
| Device Name: | PARI PEP THERAPY SYSTEM |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | PARI HOLDING CO. 13800 HULL ST. RD. Midlothian, VA 23112 |
| Contact | Miguel A Arrizon |
| Correspondent | Miguel A Arrizon PARI HOLDING CO. 13800 HULL ST. RD. 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 | 1997-06-02 |
| Decision Date | 1997-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229100355 | K972042 | 000 |