H3+ Holter Recorder
FDA 510(k) K152626 · Mortara Instrument, Inc.
510(k) numberK152626
Submission
- Device name
- H3+ Holter Recorder
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- September 15, 2015
- Decision date
- February 26, 2016
- 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 H3+ Holter Recorder cleared by the FDA?
H3+ Holter Recorder (K152626) received a 510(k) decision of Substantially Equivalent on February 26, 2016, 164 days after the submission was received.
What is the product code of K152626?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.