Atlas FDA

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.