The following data is part of a premarket notification filed by Pari Holding Co. with the FDA for Rc Cornet, Model #44f50.
| Device ID | K983308 |
| 510k Number | K983308 |
| Device Name: | RC CORNET, MODEL #44F50 |
| 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 | 1998-09-21 |
| Decision Date | 1999-06-04 |