The following data is part of a premarket notification filed by Sentry Medical Products, Inc. with the FDA for Infant Electrode Belt.
| Device ID | K830362 |
| 510k Number | K830362 |
| Device Name: | INFANT ELECTRODE BELT |
| Classification | Electrode, Electrocardiograph |
| Applicant | SENTRY MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-03 |
| Decision Date | 1983-06-03 |