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FDA 510(k)

NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)

K-Number: K040913 · 2004-07-23

ApplicantBausch & Lomb
Decision Date2004-07-23
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb. It received FDA 510(k) clearance on 2004-07-23 under 510(k) number K040913. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)?

NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) is a medical device that received FDA 510(k) clearance on 2004-07-23. The listed applicant is Bausch & Lomb. The 510(k) number is K040913.

When did NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) receive FDA 510(k) clearance?

NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) received FDA 510(k) clearance on 2004-07-23, under 510(k) number K040913.

Who is the listed applicant for NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)?

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

What is the FDA product code for NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)?

The FDA product code for NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) is MXK.

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Related Devices (Code: MXK)

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.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey CorporationK223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbH

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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