PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
FDA 510(k) clearance K071391 · decided 2007-09-07
Clearance details
- K-number
- K071391
- Device name
- PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-18
- Decision date
- 2007-09-07
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- MSX
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.