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FDA 510(k)

TECA PREMIERE

K-Number: K953732 · 1995-10-19

ApplicantMedelec , Ltd.
Decision Date1995-10-19
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TECA PREMIERE is the device name listed in this FDA 510(k) record. The listed applicant is Medelec , Ltd.. It received FDA 510(k) clearance on 1995-10-19 under 510(k) number K953732. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECA PREMIERE?

TECA PREMIERE is a medical device that received FDA 510(k) clearance on 1995-10-19. The listed applicant is Medelec , Ltd.. The 510(k) number is K953732.

When did TECA PREMIERE receive FDA 510(k) clearance?

TECA PREMIERE received FDA 510(k) clearance on 1995-10-19, under 510(k) number K953732.

Who is the listed applicant for TECA PREMIERE?

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 TECA PREMIERE?

The FDA product code for TECA PREMIERE is GWJ.

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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 SYSTEMK953799DG EXAMINER PLUSK934670DG 3P SYSTEMK934669ARC

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Related Devices (Code: GWJ)

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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