K041412 is an FDA 510(k) clearance for the ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Respironics California, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 18, 2004, 22 days after receiving the submission on May 27, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K041412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2004 |
| Decision Date | June 18, 2004 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |