FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
FDA 510(k) clearance K083892 · decided 2009-03-19
Clearance details
- K-number
- K083892
- Device name
- FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
- Applicant
- Cas Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-29
- Decision date
- 2009-03-19
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Branford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.