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FDA 510(k)

EMG MODULE, EMG1, W/OPTIONAL SPEAKER

K-Number: K842124 · 1984-08-08

ApplicantEndotek Corp.
Decision Date1984-08-08
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EMG MODULE, EMG1, W/OPTIONAL SPEAKER is the device name listed in this FDA 510(k) record. The listed applicant is Endotek Corp.. It received FDA 510(k) clearance on 1984-08-08 under 510(k) number K842124. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMG MODULE, EMG1, W/OPTIONAL SPEAKER?

EMG MODULE, EMG1, W/OPTIONAL SPEAKER is a medical device that received FDA 510(k) clearance on 1984-08-08. The listed applicant is Endotek Corp.. The 510(k) number is K842124.

When did EMG MODULE, EMG1, W/OPTIONAL SPEAKER receive FDA 510(k) clearance?

EMG MODULE, EMG1, W/OPTIONAL SPEAKER received FDA 510(k) clearance on 1984-08-08, under 510(k) number K842124.

Who is the listed applicant for EMG MODULE, EMG1, W/OPTIONAL SPEAKER?

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

What is the FDA product code for EMG MODULE, EMG1, W/OPTIONAL SPEAKER?

The FDA product code for EMG MODULE, EMG1, W/OPTIONAL SPEAKER is FAP.

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 Endotek Corp. 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.

K802374ROBERTSON OBTURATION MONITOR INSUFFLA

Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., Inc.

Official Source

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