K780340 is an FDA 510(k) clearance for the IMV SYSTEM. This device is classified as a Bottle, Collection, Breathing System (calibrated) (Class II - Special Controls, product code CBD).
Submitted by Lkb Instruments, Inc.. The FDA issued a Cleared decision on November 27, 1978, 271 days after receiving the submission on March 1, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K780340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1978 |
| Decision Date | November 27, 1978 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | CBD — Bottle, Collection, Breathing System (calibrated) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |