BTL-08 ECG Recorder Model BTL-08 ECG LC Plus, BTL-08 ECG LT Plus
FDA 510(k) K100310 · BTL Industries, Inc.
510(k) numberK100310
Submission
- Device name
- BTL-08 ECG Recorder Model BTL-08 ECG LC Plus, BTL-08 ECG LT Plus
- Applicant
- BTL Industries, Inc.
Austin, TX, US - Received
- February 3, 2010
- Decision date
- October 13, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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Questions and answers
When was BTL-08 ECG Recorder Model BTL-08 ECG LC Plus, BTL-08 ECG LT Plus cleared by the FDA?
BTL-08 ECG Recorder Model BTL-08 ECG LC Plus, BTL-08 ECG LT Plus (K100310) received a 510(k) decision of Substantially Equivalent on October 13, 2010, 252 days after the submission was received.
What is the product code of K100310?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.