Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STEREO AUDITORY TRAINER (MODEL PM228)

K-Number: K810031 · 1981-03-04

ApplicantHc Electronics
Decision Date1981-03-04
Product CodeEPF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STEREO AUDITORY TRAINER (MODEL PM228) is the device name listed in this FDA 510(k) record. The listed applicant is Hc Electronics. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K810031. 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 STEREO AUDITORY TRAINER (MODEL PM228)?

STEREO AUDITORY TRAINER (MODEL PM228) is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Hc Electronics. The 510(k) number is K810031.

When did STEREO AUDITORY TRAINER (MODEL PM228) receive FDA 510(k) clearance?

STEREO AUDITORY TRAINER (MODEL PM228) received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810031.

Who is the listed applicant for STEREO AUDITORY TRAINER (MODEL PM228)?

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

What is the FDA product code for STEREO AUDITORY TRAINER (MODEL PM228)?

The FDA product code for STEREO AUDITORY TRAINER (MODEL PM228) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hc Electronics 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.

K810030POST-AURICULAR HEARING AID (#PE830)K800340PHONIC EAR, MODEL 841LK782053HEARING AID, POST-AURICULARK780936PHONIC EARK780363PHONIC EARK772347PHONIC MIRROR HANDIVOICE MODEL 120

View all 10 devices →

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.

↑