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FDA 510(k)

ELMED RF-ALERT

K-Number: K953271 · 1996-01-18

ApplicantElmed, Inc.
Decision Date1996-01-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELMED RF-ALERT is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1996-01-18 under 510(k) number K953271. 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 RF-ALERT?

ELMED RF-ALERT is a medical device that received FDA 510(k) clearance on 1996-01-18. The listed applicant is Elmed, Inc.. The 510(k) number is K953271.

When did ELMED RF-ALERT receive FDA 510(k) clearance?

ELMED RF-ALERT received FDA 510(k) clearance on 1996-01-18, under 510(k) number K953271.

Who is the listed applicant for ELMED RF-ALERT?

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 RF-ALERT?

The FDA product code for ELMED RF-ALERT 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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK952110ELMED 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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Related Devices (Code: GEI)

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

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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