POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
FDA 510(k) clearance K091943 · decided 2009-09-10
Clearance details
- K-number
- K091943
- Device name
- POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A
- Applicant
- Cardiac Science Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-06-30
- Decision date
- 2009-09-10
- Days to decision
- 72 days
- Clearance type
- Special
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardiac Science Corporation
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.