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FDA 510(k)

MODEL S10CTCM AUDITORY STIMULATOR

K-Number: K810539 · 1981-03-17

ApplicantGrass Instrument Co.
Decision Date1981-03-17
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL S10CTCM AUDITORY STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Grass Instrument Co.. It received FDA 510(k) clearance on 1981-03-17 under 510(k) number K810539. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL S10CTCM AUDITORY STIMULATOR?

MODEL S10CTCM AUDITORY STIMULATOR is a medical device that received FDA 510(k) clearance on 1981-03-17. The listed applicant is Grass Instrument Co.. The 510(k) number is K810539.

When did MODEL S10CTCM AUDITORY STIMULATOR receive FDA 510(k) clearance?

MODEL S10CTCM AUDITORY STIMULATOR received FDA 510(k) clearance on 1981-03-17, under 510(k) number K810539.

Who is the listed applicant for MODEL S10CTCM AUDITORY STIMULATOR?

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

What is the FDA product code for MODEL S10CTCM AUDITORY STIMULATOR?

The FDA product code for MODEL S10CTCM AUDITORY STIMULATOR is GWJ.

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 Grass Instrument Co. 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.

K021807GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEMK994142GRASS TS3201/6401 EEG AMPLIFIER SYSTEMK844216GRASS MODEL NL FACIAL NERVE LOCATOR & MONITORK812061MODEL S10VS VISUAL STIMULATORK771742EVOKED RESPONSE SYS., MODEL 10

Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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