K212317 is an FDA 510(k) clearance for the Eclipse MINI Model 98900. This device is classified as a Electrocardiograph, Ambulatory (without Analysis) (Class II - Special Controls, product code MWJ).
Submitted by Spacelabs Healthcare, Ltd. (Hertford, GB). The FDA issued a Cleared decision on November 7, 2022, 469 days after receiving the submission on July 26, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K212317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2021 |
| Decision Date | November 07, 2022 |
| Days to Decision | 469 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWJ - Electrocardiograph, Ambulatory (without Analysis) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |