The following data is part of a premarket notification filed by Sentry Medical Products, Inc. with the FDA for Infant Limb Electrode.
| Device ID | K844632 |
| 510k Number | K844632 |
| Device Name: | INFANT LIMB ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | SENTRY MEDICAL PRODUCTS, INC. 2615 SOUTH ORANGE AVE. Santa Ana, CA 92704 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1985-01-14 |