K253293 is an FDA 510(k) clearance for the VitaloJAK Clinic (Model 7100). This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Vitalograph , Ltd. (Ennis Co. Clare, IE). The FDA issued a Cleared decision on December 3, 2025, 65 days after receiving the submission on September 29, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K253293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2025 |
| Decision Date | December 03, 2025 |
| Days to Decision | 65 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DSH - Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |