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FDA 510(k)

ELECTROSONOGRAM ESG-1

K-Number: K905449 · 1991-04-26

ApplicantMyo-Tronics, Inc.
Decision Date1991-04-26
Product CodeNFQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELECTROSONOGRAM ESG-1 is the device name listed in this FDA 510(k) record. The listed applicant is Myo-Tronics, Inc.. It received FDA 510(k) clearance on 1991-04-26 under 510(k) number K905449. The device is classified under product code NFQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROSONOGRAM ESG-1?

ELECTROSONOGRAM ESG-1 is a medical device that received FDA 510(k) clearance on 1991-04-26. The listed applicant is Myo-Tronics, Inc.. The 510(k) number is K905449.

When did ELECTROSONOGRAM ESG-1 receive FDA 510(k) clearance?

ELECTROSONOGRAM ESG-1 received FDA 510(k) clearance on 1991-04-26, under 510(k) number K905449.

Who is the listed applicant for ELECTROSONOGRAM ESG-1?

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

What is the FDA product code for ELECTROSONOGRAM ESG-1?

The FDA product code for ELECTROSONOGRAM ESG-1 is NFQ.

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 Myo-Tronics, 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.

K970116ESG-1 ELECTROSONOGRAM (ESG-1)K944134K6-1 DIAGNOSTIC SYSTEM VERSION 3.1K922270PHYSIOTECH 4000 OR NORODYN 8000K922456K6-I DIAGNOSTIC SYSTEMK921919MS-100 MYO-SCANNER OR MS-100 EMG SCANNER

Related Devices (Code: NFQ)

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.

K970116ESG-1 ELECTROSONOGRAM (ESG-1)Myo-Tronics, Inc.K905657SONOPAK/QS, SONOPAKBioresearchK862286ARTHROPHONOMETERArthrotek, 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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