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FDA 510(k)

DIRECT VIEW 2001 FIBERLIGHT

K-Number: K945901 · 1994-12-27

ApplicantMercury Medical
Decision Date1994-12-27
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DIRECT VIEW 2001 FIBERLIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Mercury Medical. It received FDA 510(k) clearance on 1994-12-27 under 510(k) number K945901. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT VIEW 2001 FIBERLIGHT?

DIRECT VIEW 2001 FIBERLIGHT is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Mercury Medical. The 510(k) number is K945901.

When did DIRECT VIEW 2001 FIBERLIGHT receive FDA 510(k) clearance?

DIRECT VIEW 2001 FIBERLIGHT received FDA 510(k) clearance on 1994-12-27, under 510(k) number K945901.

Who is the listed applicant for DIRECT VIEW 2001 FIBERLIGHT?

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

What is the FDA product code for DIRECT VIEW 2001 FIBERLIGHT?

The FDA product code for DIRECT VIEW 2001 FIBERLIGHT is CCW.

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Other records listing Mercury Medical 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: CCW)

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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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