K801890 is an FDA 510(k) clearance for the IC-2 VENTILATOR. This device is classified as a Ventilator, Continuous, Facility Use (Class II - Special Controls, product code CBK).
Submitted by Bio-Med Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 18, 1980, 102 days after receiving the submission on August 8, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K801890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1980 |
| Decision Date | November 18, 1980 |
| Days to Decision | 102 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 |