Healthepod
FDA 510(k) K083174 · Card Guard Scientific Survival , Ltd.
510(k) numberK083174
Submission
- Device name
- Healthepod
- Applicant
- Card Guard Scientific Survival , Ltd.
Rehovot, IL - Received
- October 27, 2008
- Decision date
- December 17, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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Questions and answers
When was Healthepod cleared by the FDA?
Healthepod (K083174) received a 510(k) decision of Substantially Equivalent on December 17, 2009, 416 days after the submission was received.
What is the product code of K083174?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.