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FDA 510(k)

DG EXAMINER PLUS

K-Number: K953799 · 1995-11-08

ApplicantMedelec , Ltd.
Decision Date1995-11-08
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DG EXAMINER PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Medelec , Ltd.. It received FDA 510(k) clearance on 1995-11-08 under 510(k) number K953799. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DG EXAMINER PLUS?

DG EXAMINER PLUS is a medical device that received FDA 510(k) clearance on 1995-11-08. The listed applicant is Medelec , Ltd.. The 510(k) number is K953799.

When did DG EXAMINER PLUS receive FDA 510(k) clearance?

DG EXAMINER PLUS received FDA 510(k) clearance on 1995-11-08, under 510(k) number K953799.

Who is the listed applicant for DG EXAMINER PLUS?

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

What is the FDA product code for DG EXAMINER PLUS?

The FDA product code for DG EXAMINER PLUS is OLT.

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Other records listing Medelec , Ltd. 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.

K965065TECA. MILLENNIUMK964280DG NERVUSK954157DG PORTABLE SYSTEMK953732TECA PREMIEREK934670DG 3P SYSTEMK934669ARC

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Related Devices (Code: OLT)

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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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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