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)

PHASIS ELECTROMYOGRAPH

K-Number: K922488 · 1993-03-02

ApplicantBiosound, Inc.
Decision Date1993-03-02
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PHASIS ELECTROMYOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1993-03-02 under 510(k) number K922488. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHASIS ELECTROMYOGRAPH?

PHASIS ELECTROMYOGRAPH is a medical device that received FDA 510(k) clearance on 1993-03-02. The listed applicant is Biosound, Inc.. The 510(k) number is K922488.

When did PHASIS ELECTROMYOGRAPH receive FDA 510(k) clearance?

PHASIS ELECTROMYOGRAPH received FDA 510(k) clearance on 1993-03-02, under 510(k) number K922488.

Who is the listed applicant for PHASIS ELECTROMYOGRAPH?

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

What is the FDA product code for PHASIS ELECTROMYOGRAPH?

The FDA product code for PHASIS ELECTROMYOGRAPH is IKN.

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 Biosound, 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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963936ACCESSPOINT, MED E-MAIL, DICOM READERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

View all 39 devices →

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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.

↑