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FDA 510(k)

ELMED ESU 300 M/M AND DIGITAL

K-Number: K932938 · 1994-05-02

ApplicantElmed, Inc.
Decision Date1994-05-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELMED ESU 300 M/M AND DIGITAL is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1994-05-02 under 510(k) number K932938. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELMED ESU 300 M/M AND DIGITAL?

ELMED ESU 300 M/M AND DIGITAL is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is Elmed, Inc.. The 510(k) number is K932938.

When did ELMED ESU 300 M/M AND DIGITAL receive FDA 510(k) clearance?

ELMED ESU 300 M/M AND DIGITAL received FDA 510(k) clearance on 1994-05-02, under 510(k) number K932938.

Who is the listed applicant for ELMED ESU 300 M/M AND DIGITAL?

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

What is the FDA product code for ELMED ESU 300 M/M AND DIGITAL?

The FDA product code for ELMED ESU 300 M/M AND DIGITAL is GEI.

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Other records listing Elmed, 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.

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Related Devices (Code: GEI)

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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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