K110525 is an FDA 510(k) clearance for the VITALOGRAPH MODEL 7100 - VITALOJAK. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Vitalograph (Ireland) , Ltd. (Ennis, Co. Clare, IE). The FDA issued a Cleared decision on November 23, 2011, 273 days after receiving the submission on February 23, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K110525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2011 |
| Decision Date | November 23, 2011 |
| Days to Decision | 273 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 |