POWERHEART ECD
FDA 510(k) clearance K052316 · decided 2006-01-03
Clearance details
- K-number
- K052316
- Device name
- POWERHEART ECD
- Applicant
- Cardiac Science, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-25
- Decision date
- 2006-01-03
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Edina, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardiac Science
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.