K853737 is an FDA 510(k) clearance for the VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM). This device is classified as a Synchronizer, Electrocardiograph, Nuclear (Class I - General Controls, product code IYY).
Submitted by Capintec, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 13, 1986, 160 days after receiving the submission on September 6, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1410.
| 510(k) Number | K853737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1985 |
| Decision Date | February 13, 1986 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | IYY - Synchronizer, Electrocardiograph, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1410 |