The following data is part of a premarket notification filed by Respironics California, Inc. with the FDA for Esprit Ventilator Speaking Mode Option, Model V1000.
| Device ID | K071212 |
| 510k Number | K071212 |
| Device Name: | ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. Carlsbad, CA 92011 |
| Contact | Mara Caler |
| Correspondent | Mara Caler RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. Carlsbad, CA 92011 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-01 |
| Decision Date | 2007-07-30 |
| Summary: | summary |