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FDA 510(k)

ELPHA 500

K-Number: K823581 · 1983-03-24

ApplicantProthia USA, Inc.
Decision Date1983-03-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELPHA 500 is the device name listed in this FDA 510(k) record. The listed applicant is Prothia USA, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K823581. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELPHA 500?

ELPHA 500 is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Prothia USA, Inc.. The 510(k) number is K823581.

When did ELPHA 500 receive FDA 510(k) clearance?

ELPHA 500 received FDA 510(k) clearance on 1983-03-24, under 510(k) number K823581.

Who is the listed applicant for ELPHA 500?

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

What is the FDA product code for ELPHA 500?

The FDA product code for ELPHA 500 is GCJ.

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Other records listing Prothia USA, Inc. 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.

K831071UNIVERSAL INSTRU. SET FOR NEUROVASCULARK830993AMPLIGREFFEK830058MYOGRAPH 2000K823583MYOTEST NERVE STIMULATOR

Related Devices (Code: GCJ)

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

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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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