K770369 is an FDA 510(k) clearance for the VACON TM. This device is classified as a Bottle, Collection, Breathing System (calibrated) (Class II - Special Controls, product code CBD).
Submitted by Diemolding Corp. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977, 5 days after receiving the submission on February 24, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K770369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1977 |
| Decision Date | March 01, 1977 |
| Days to Decision | 5 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 |