M2376 DEVICELINK SYSTEM
FDA 510(k) clearance K021912 · decided 2002-06-24
Clearance details
- K-number
- K021912
- Device name
- M2376 DEVICELINK SYSTEM
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-11
- Decision date
- 2002-06-24
- Days to decision
- 13 days
- Clearance type
- Special
- Product code
- MWI
- 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.