The following data is part of a premarket notification filed by Pari Innovative Manufacturers, Inc. with the FDA for Pari Hydrate G.
| Device ID | K070107 |
| 510k Number | K070107 |
| Device Name: | PARI HYDRATE G |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | PARI INNOVATIVE MANUFACTURERS, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Contact | Michael Judge |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-11 |
| Decision Date | 2007-02-23 |
| Summary: | summary |