The following data is part of a premarket notification filed by Pari Innovative Manufacturers, Inc. with the FDA for Vortex Valved Holding Chamber.
| Device ID | K020944 |
| 510k Number | K020944 |
| Device Name: | VORTEX VALVED HOLDING CHAMBER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI INNOVATIVE MANUFACTURERS, INC. 13800 HULL ST. RD. Midlothian, VA 23112 |
| Contact | Lawrence Weinstein |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-03-25 |
| Decision Date | 2002-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229510444 | K020944 | 000 |
| 00744229510055 | K020944 | 000 |
| 00744229510291 | K020944 | 000 |
| 00744229510307 | K020944 | 000 |
| 00744229510338 | K020944 | 000 |
| 00744229510369 | K020944 | 000 |
| 00744229510383 | K020944 | 000 |
| 00744229510406 | K020944 | 000 |
| 00744229510420 | K020944 | 000 |
| 00744229510017 | K020944 | 000 |