The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Vest(ambulatory Ventricular Evaluating System).
| Device ID | K853737 |
| 510k Number | K853737 |
| Device Name: | VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) |
| Classification | Synchronizer, Electrocardiograph, Nuclear |
| Applicant | CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Joel Orlinsky |
| Correspondent | Joel Orlinsky CAPINTEC, INC. 540 ALPHA DR. Pittsburgh, PA 15238 |
| Product Code | IYY |
| CFR Regulation Number | 892.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-06 |
| Decision Date | 1986-02-13 |