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FDA 510(k)

PHILIPS M5066A AND M5068A

K-Number: K020715 · 2002-11-08

ApplicantPhilips Medical Systems
Decision Date2002-11-08
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PHILIPS M5066A AND M5068A is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2002-11-08 under 510(k) number K020715. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the PHILIPS M5066A AND M5068A?

PHILIPS M5066A AND M5068A is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is Philips Medical Systems. The 510(k) number is K020715.

When did PHILIPS M5066A AND M5068A receive FDA 510(k) clearance?

PHILIPS M5066A AND M5068A received FDA 510(k) clearance on 2002-11-08, under 510(k) number K020715.

Who is the listed applicant for PHILIPS M5066A AND M5068A?

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

What is the FDA product code for PHILIPS M5066A AND M5068A?

The FDA product code for PHILIPS M5066A AND M5068A is MKJ. This falls under the Dental category.

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Other records listing Philips Medical Systems as applicant

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Related Devices (Code: MKJ)

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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