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FDA 510(k)

MERIT (O.1T MR SYSTEM)

K-Number: K943415 · 1994-12-15

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1994-12-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MERIT (O.1T MR SYSTEM) 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 1994-12-15 under 510(k) number K943415. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERIT (O.1T MR SYSTEM)?

MERIT (O.1T MR SYSTEM) is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K943415.

When did MERIT (O.1T MR SYSTEM) receive FDA 510(k) clearance?

MERIT (O.1T MR SYSTEM) received FDA 510(k) clearance on 1994-12-15, under 510(k) number K943415.

Who is the listed applicant for MERIT (O.1T MR SYSTEM)?

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 MERIT (O.1T MR SYSTEM)?

The FDA product code for MERIT (O.1T MR SYSTEM) is LNH.

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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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