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FDA 510(k)

THERASTIM

K-Number: K914813 · 1991-12-31

ApplicantPrecision Electronics , Ltd.
Decision Date1991-12-31
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THERASTIM is the device name listed in this FDA 510(k) record. The listed applicant is Precision Electronics , Ltd.. It received FDA 510(k) clearance on 1991-12-31 under 510(k) number K914813. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERASTIM?

THERASTIM is a medical device that received FDA 510(k) clearance on 1991-12-31. The listed applicant is Precision Electronics , Ltd.. The 510(k) number is K914813.

When did THERASTIM receive FDA 510(k) clearance?

THERASTIM received FDA 510(k) clearance on 1991-12-31, under 510(k) number K914813.

Who is the listed applicant for THERASTIM?

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

What is the FDA product code for THERASTIM?

The FDA product code for THERASTIM is GZJ.

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Related Devices (Code: GZJ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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