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FDA 510(k)

ENDOSCOPIC ANTI FOG DEVICE

K-Number: K993604 · 2000-03-03

ApplicantMectra Labs, Inc.
Decision Date2000-03-03
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC ANTI FOG DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Mectra Labs, Inc.. It received FDA 510(k) clearance on 2000-03-03 under 510(k) number K993604. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC ANTI FOG DEVICE?

ENDOSCOPIC ANTI FOG DEVICE is a medical device that received FDA 510(k) clearance on 2000-03-03. The listed applicant is Mectra Labs, Inc.. The 510(k) number is K993604.

When did ENDOSCOPIC ANTI FOG DEVICE receive FDA 510(k) clearance?

ENDOSCOPIC ANTI FOG DEVICE received FDA 510(k) clearance on 2000-03-03, under 510(k) number K993604.

Who is the listed applicant for ENDOSCOPIC ANTI FOG DEVICE?

The FDA 510(k) record lists Mectra Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPIC ANTI FOG DEVICE?

The FDA product code for ENDOSCOPIC ANTI FOG DEVICE is OCT.

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Other records listing Mectra Labs, Inc. as applicant

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Related Devices (Code: OCT)

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.

K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc.K221293E-Brik Visualization AssistantJdi Surgical, Inc.K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal UrunlerK181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd.K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLC

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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