POWERHEART AED G3 PRO
FDA 510(k) clearance K040637 · decided 2004-08-06
Clearance details
- K-number
- K040637
- Device name
- POWERHEART AED G3 PRO
- Applicant
- Cardiac Science, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-10
- Decision date
- 2004-08-06
- Days to decision
- 149 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
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