K844632 is an FDA 510(k) clearance for the INFANT LIMB ELECTRODE. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by Sentry Medical Products, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 14, 1985, 48 days after receiving the submission on November 27, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K844632 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 1984 |
| Decision Date | January 14, 1985 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRX — Electrode, Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2360 |