Kenz CARDY302 Max
FDA 510(k) K101024 · Suzuken Co., Ltd.
510(k) numberK101024
Submission
- Device name
- Kenz CARDY302 Max
- Applicant
- Suzuken Co., Ltd.
Richardson, TX, US - Received
- April 13, 2010
- Decision date
- January 6, 2011
- 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 Kenz CARDY302 Max cleared by the FDA?
Kenz CARDY302 Max (K101024) received a 510(k) decision of Substantially Equivalent on January 6, 2011, 268 days after the submission was received.
What is the product code of K101024?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.