K981072 is an FDA 510(k) clearance for the ESPRIT VENTILATOR. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 12, 1998, 233 days after receiving the submission on March 24, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K981072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | March 24, 1998 |
| Decision Date | November 12, 1998 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBK — Ventilator, Continuous, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |