The following data is part of a premarket notification filed by Btl Industries, Inc with the FDA for Btl-08 Ecg Recorder Model Btl-08 Ecg Lc Plus, Btl-08 Ecg Lt Plus.
| Device ID | K100310 |
| 510k Number | K100310 |
| Device Name: | BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | BTL INDUSTRIES, INC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Richard Vincins, Cqa, Rac (us,eu) |
| Correspondent | Richard Vincins, Cqa, Rac (us,eu) BTL INDUSTRIES, INC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-03 |
| Decision Date | 2010-10-13 |