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FDA 510(k)

STIMRITE

K-Number: K821691 · 1982-08-25

ApplicantBiotone International, Inc.
Decision Date1982-08-25
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STIMRITE is the device name listed in this FDA 510(k) record. The listed applicant is Biotone International, Inc.. It received FDA 510(k) clearance on 1982-08-25 under 510(k) number K821691. The device is classified under product code EPF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STIMRITE?

STIMRITE is a medical device that received FDA 510(k) clearance on 1982-08-25. The listed applicant is Biotone International, Inc.. The 510(k) number is K821691.

When did STIMRITE receive FDA 510(k) clearance?

STIMRITE received FDA 510(k) clearance on 1982-08-25, under 510(k) number K821691.

Who is the listed applicant for STIMRITE?

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

What is the FDA product code for STIMRITE?

The FDA product code for STIMRITE is EPF.

Related Clinical Trials

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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Other records listing Biotone International, 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.

K821692PASSIVE HEAT PADSK812538ELITEK811737BIO-TONE MODEL 4

Related Devices (Code: EPF)

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.

K982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONTelex Communications, Inc.K974658INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, ITPhonic Ear, Inc.K974287FM RECEIVER - AUDITORY TRAINERPhonic Ear, Inc.K970687WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK970665WILLIAMS SOUND, PERSONAL FM, HEARING HELPERWilliams Sound, LLCK960567HF MEGA EARMaxi-Aids, Inc.

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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