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FDA 510(k)

INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL

K-Number: K101600 · 2010-08-31

ApplicantPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
Decision Date2010-08-31
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K101600. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL?

INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The 510(k) number is K101600.

When did INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL receive FDA 510(k) clearance?

INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL received FDA 510(k) clearance on 2010-08-31, under 510(k) number K101600.

Who is the listed applicant for INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL?

The FDA 510(k) record lists Philips Medizinsysteme Boeblingen GmbH, Cardiac AN as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL?

The FDA product code for INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL is DQA.

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Other records listing Philips Medizinsysteme Boeblingen GmbH, Cardiac AN as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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