FDA 510(k)

FACTS

K-Number: K982010 · 1998-11-19

ApplicantPhilips Medical Systems (Cleveland), Inc.

Decision Date1998-11-19

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FACTS is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1998-11-19 under 510(k) number K982010. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACTS?

FACTS is a medical device that received FDA 510(k) clearance on 1998-11-19. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K982010.

When did FACTS receive FDA 510(k) clearance?

FACTS received FDA 510(k) clearance on 1998-11-19, under 510(k) number K982010.

Who is the listed applicant for FACTS?

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

What is the FDA product code for FACTS?

The FDA product code for FACTS is JAK.

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Related Devices (Code: JAK)

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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.