HEARTSTART MRX, MODEL M3535A
FDA 510(k) clearance K040404 · decided 2004-05-04
Clearance details
- K-number
- K040404
- Device name
- HEARTSTART MRX, MODEL M3535A
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-17
- Decision date
- 2004-05-04
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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