K230184 is an FDA 510(k) clearance for the Holter ECG and ABP System. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on September 25, 2023, 245 days after receiving the submission on January 23, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K230184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2023 |
| Decision Date | September 25, 2023 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSH — Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |