LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA 510(k) clearance K011144 · decided 2001-12-03
Clearance details
- K-number
- K011144
- Device name
- LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
- Applicant
- Medtronic Physio-Control Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-16
- Decision date
- 2001-12-03
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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