FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M
FDA 510(k) clearance K083697 · decided 2009-03-19
Clearance details
- K-number
- K083697
- Device name
- FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M
- Applicant
- Fukuda Denshi USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-15
- Decision date
- 2009-03-19
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.