The following data is part of a premarket notification filed by Respironics California, Inc. with the FDA for V60 Ventilator With Ppv And Auto-trak+ Software Options.
| Device ID | K102985 |
| 510k Number | K102985 |
| Device Name: | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. Carlsbad, CA 92011 |
| Contact | Tamatha Ley |
| Correspondent | Tamatha Ley RESPIRONICS CALIFORNIA, INC. 2271 COSMOS CT. Carlsbad, CA 92011 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-07 |
| Decision Date | 2011-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838050921 | K102985 | 000 |
| 00884838015883 | K102985 | 000 |
| 00884838015852 | K102985 | 000 |
| 00884838015845 | K102985 | 000 |
| 00884838015838 | K102985 | 000 |
| 00884838015821 | K102985 | 000 |
| 00884838015807 | K102985 | 000 |
| 00884838015791 | K102985 | 000 |
| 00884838015753 | K102985 | 000 |
| 00884838015739 | K102985 | 000 |
| 00884838015722 | K102985 | 000 |
| 00884838009868 | K102985 | 000 |
| 00884838009851 | K102985 | 000 |
| 00884838015890 | K102985 | 000 |
| 00884838015906 | K102985 | 000 |
| 00884838015913 | K102985 | 000 |
| 00884838050402 | K102985 | 000 |
| 00884838045248 | K102985 | 000 |
| 00884838045057 | K102985 | 000 |
| 00884838045040 | K102985 | 000 |
| 00884838045033 | K102985 | 000 |
| 00884838044692 | K102985 | 000 |
| 00884838033832 | K102985 | 000 |
| 00884838028210 | K102985 | 000 |
| 00884838028203 | K102985 | 000 |
| 00884838025776 | K102985 | 000 |
| 00884838020429 | K102985 | 000 |
| 00884838015920 | K102985 | 000 |
| 00884838009844 | K102985 | 000 |