The following data is part of a premarket notification filed by Respironics California, Inc. with the FDA for V200 Intelli-trak Option.
| Device ID | K110795 |
| 510k Number | K110795 |
| Device Name: | V200 INTELLI-TRAK OPTION |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | RESPIRONICS CALIFORNIA, INC. 3919 WILLIAM PENN HIGHWAY, SUITE 200 Murrysville, PA 15668 -8550 |
| Contact | Robert M Marshall |
| Correspondent | Robert M Marshall RESPIRONICS CALIFORNIA, INC. 3919 WILLIAM PENN HIGHWAY, SUITE 200 Murrysville, PA 15668 -8550 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-22 |
| Decision Date | 2011-08-19 |
| Summary: | summary |