ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
FDA 510(k) clearance K162768 · decided 2017-08-16
Clearance details
- K-number
- K162768
- Device name
- ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
- Applicant
- Integral Process Sas
- Decision
- Substantially Equivalent
- Date received
- 2016-09-30
- Decision date
- 2017-08-16
- Days to decision
- 320 days
- Clearance type
- Abbreviated
- Product code
- DSA
- Device class
- 2
- Regulation number
- 870.2900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Conflans Sainte Honorine, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.