OSCILLOMATE EMS NIBP MONITOR MODEL 9001
FDA 510(k) clearance K982135 · decided 1998-09-15
Clearance details
- K-number
- K982135
- Device name
- OSCILLOMATE EMS NIBP MONITOR MODEL 9001
- Applicant
- Cas Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-17
- Decision date
- 1998-09-15
- Days to decision
- 90 days
- Clearance type
- Abbreviated
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- 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.