FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYSENSE HEART
K Number: K113176
·
Decision Dec 21, 2011
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
10
Review Days
54
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Basic Information
- Device Name
- MYSENSE HEART
- K Number
- K113176
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiac Science Corporation
- Date Received
- October 28, 2011
- Decision Date
- December 21, 2011
- Product Code
- DSH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiac Science Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K143714 | Powerheart G5 AED | May 4, 2015 | Substantially Equivalent |
| K122758 | POWERHEART G5 AED | Feb 12, 2014 | Substantially Equivalent |
| K102496 | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS | Jun 9, 2011 | Substantially Equivalent |
| K093211 | CARECENTER MD | Jun 3, 2010 | Substantially Equivalent |
| K091943 | POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A | Sep 10, 2009 | Substantially Equivalent |
| K082090 | 9131 DEFIBRILLATION ELECTRODES | Dec 12, 2008 | Substantially Equivalent |
| K082173 | Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S | Aug 26, 2008 | Substantially Equivalent |
| K060934 | MODIFICATION TO POWERHEART ECD | May 15, 2006 | Substantially Equivalent |
| K060167 | ATRIA 3100, ATRIA 6100 | Apr 19, 2006 | Substantially Equivalent |