The following data is part of a premarket notification filed by Pari Holding Co. with the FDA for Proneb Ultra Model Number 85b0100.
| Device ID | K002862 |
| 510k Number | K002862 |
| Device Name: | PRONEB ULTRA MODEL NUMBER 85B0100 |
| Classification | Compressor, Air, Portable |
| Applicant | PARI HOLDING CO. 13800 HULL ST. RD. Midlothian, VA 23112 |
| Contact | Debra A Pekar |
| Correspondent | Debra A Pekar PARI HOLDING CO. 13800 HULL ST. RD. Midlothian, VA 23112 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2001-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229850342 | K002862 | 000 |
| 00744229312512 | K002862 | 000 |
| 00744229312536 | K002862 | 000 |
| 00744229312529 | K002862 | 000 |
| 00744229100317 | K002862 | 000 |
| 00744229100386 | K002862 | 000 |
| 00744229100393 | K002862 | 000 |
| 00744229100362 | K002862 | 000 |
| 00744229100379 | K002862 | 000 |
| 00744229850359 | K002862 | 000 |
| 00744229312505 | K002862 | 000 |