The following data is part of a premarket notification filed by Pari Holding Co. with the FDA for Pari Baby.
| Device ID | K944152 |
| 510k Number | K944152 |
| Device Name: | PARI BABY |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI HOLDING CO. 7493 WHITEPINE RD. Richmond, VA 23237 |
| Contact | Miguel A Arrizon |
| Correspondent | Miguel A Arrizon PARI HOLDING CO. 7493 WHITEPINE RD. Richmond, VA 23237 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-22 |
| Decision Date | 1994-11-18 |