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FDA 510(k)

SAPPHIRE PREMIERE

K-Number: K923303 · 1992-11-24

ApplicantMedelec , Ltd.
Decision Date1992-11-24
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE 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 1992-11-24 under 510(k) number K923303. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPPHIRE PREMIERE?

SAPPHIRE PREMIERE is a medical device that received FDA 510(k) clearance on 1992-11-24. The listed applicant is Medelec , Ltd.. The 510(k) number is K923303.

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

SAPPHIRE PREMIERE received FDA 510(k) clearance on 1992-11-24, under 510(k) number K923303.

Who is the listed applicant for SAPPHIRE 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 SAPPHIRE PREMIERE?

The FDA product code for SAPPHIRE PREMIERE is GWF.

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Other records listing Medelec , Ltd. as applicant

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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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