NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT
FDA 510(k) clearance K082599 · decided 2008-10-17
Clearance details
- K-number
- K082599
- Device name
- NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT
- Applicant
- Cnsystem Medizintechnik AG
- Decision
- Substantially Equivalent
- Date received
- 2008-09-08
- Decision date
- 2008-10-17
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Graz, AT
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.