INTELLIVUE PATIENT MONITOR
FDA 510(k) clearance K120366 · decided 2012-07-18
Clearance details
- K-number
- K120366
- Device name
- INTELLIVUE PATIENT MONITOR
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2012-02-06
- Decision date
- 2012-07-18
- Days to decision
- 163 days
- Clearance type
- Abbreviated
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, Baden-Wuerttemberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.