The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for Pari Vios.
| Device ID | K092918 |
| 510k Number | K092918 |
| Device Name: | PARI VIOS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI RESPIRATORY EQUIPMENT, INC. 2943 OAK LAKE BLVD. Midlothian, VA 23112 |
| Contact | Michael Judge |
| Correspondent | Michael Judge PARI RESPIRATORY EQUIPMENT, INC. 2943 OAK LAKE BLVD. Midlothian, VA 23112 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2010-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229311058 | K092918 | 000 |
| 00744229311027 | K092918 | 000 |
| 00744229311034 | K092918 | 000 |
| 00744229311041 | K092918 | 000 |
| 00744229311065 | K092918 | 000 |
| 00744229311072 | K092918 | 000 |
| 00744229311089 | K092918 | 000 |
| 00744229311096 | K092918 | 000 |
| 00744229311102 | K092918 | 000 |
| 00744229311133 | K092918 | 000 |
| 00744229311140 | K092918 | 000 |
| 00744229311157 | K092918 | 000 |
| 00744229311164 | K092918 | 000 |
| 00744229311171 | K092918 | 000 |
| 00744229310846 | K092918 | 000 |
| 00744229311119 | K092918 | 000 |
| 00744229311188 | K092918 | 000 |
| 00744229311126 | K092918 | 000 |
| 00744229311010 | K092918 | 000 |