INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
FDA 510(k) clearance K052801 · decided 2005-11-02
Clearance details
- K-number
- K052801
- Device name
- INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-10-03
- Decision date
- 2005-11-02
- Days to decision
- 30 days
- Clearance type
- Special
- 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.