Mysense Heart
FDA 510(k) K113176 · Cardiac Science Corporation
510(k) numberK113176
Submission
- Device name
- Mysense Heart
- Applicant
- Cardiac Science Corporation
Bothell, WA, US - Received
- October 28, 2011
- Decision date
- December 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K082173 | Q-Stress and Heartstride, Models QSTRESS/Q40 and H4/H4SDPS · Special | 08/26/2008SE |
| K060934 | Modification to Powerheart EcdMKJ · Special | 05/15/2006SE |
| K060167 | Atria 3100, Atria 6100DPS · Abbreviated | 04/19/2006SE |
| K052316 | Powerheart EcdMKJ · Traditional | 01/03/2006SE |
Questions and answers
When was Mysense Heart cleared by the FDA?
Mysense Heart (K113176) received a 510(k) decision of Substantially Equivalent on December 21, 2011, 54 days after the submission was received.
What is the product code of K113176?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.