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FDA 510(k)

ELMED ESU 120 M/M DIGITAL

K-Number: K974793 · 1998-03-19

ApplicantElmed, Inc.
Decision Date1998-03-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELMED ESU 120 M/M 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 1998-03-19 under 510(k) number K974793. 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 120 M/M DIGITAL?

ELMED ESU 120 M/M DIGITAL is a medical device that received FDA 510(k) clearance on 1998-03-19. The listed applicant is Elmed, Inc.. The 510(k) number is K974793.

When did ELMED ESU 120 M/M DIGITAL receive FDA 510(k) clearance?

ELMED ESU 120 M/M DIGITAL received FDA 510(k) clearance on 1998-03-19, under 510(k) number K974793.

Who is the listed applicant for ELMED ESU 120 M/M 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 120 M/M DIGITAL?

The FDA product code for ELMED ESU 120 M/M DIGITAL is GEI.

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Other records listing Elmed, Inc. as applicant

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K010465DENSTATK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITALK921770ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M

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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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