K100310 is an FDA 510(k) clearance for the BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS. This device is classified as a Electrocardiograph, Ambulatory (without Analysis) (Class II - Special Controls, product code MWJ).
Submitted by BTL Industries, Inc. (Austin, US). The FDA issued a Cleared decision on October 13, 2010, 252 days after receiving the submission on February 3, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K100310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2010 |
| Decision Date | October 13, 2010 |
| Days to Decision | 252 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 |