MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS
FDA 510(k) clearance K071426 · decided 2007-06-13
Clearance details
- K-number
- K071426
- Device name
- MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2007-05-23
- Decision date
- 2007-06-13
- Days to decision
- 21 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.