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FDA 510(k)

PHILIPS ESSENTA DR

K-Number: K070528 · 2007-03-09

ApplicantPhilips Medical Systems GmbH, Dmc
Decision Date2007-03-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHILIPS ESSENTA DR is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems GmbH, Dmc. It received FDA 510(k) clearance on 2007-03-09 under 510(k) number K070528. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS ESSENTA DR?

PHILIPS ESSENTA DR is a medical device that received FDA 510(k) clearance on 2007-03-09. The listed applicant is Philips Medical Systems GmbH, Dmc. The 510(k) number is K070528.

When did PHILIPS ESSENTA DR receive FDA 510(k) clearance?

PHILIPS ESSENTA DR received FDA 510(k) clearance on 2007-03-09, under 510(k) number K070528.

Who is the listed applicant for PHILIPS ESSENTA DR?

The FDA 510(k) record lists Philips Medical Systems GmbH, Dmc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHILIPS ESSENTA DR?

The FDA product code for PHILIPS ESSENTA DR is MQB.

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Official Source

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

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