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FDA 510(k)

BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.

K-Number: K884852 · 1989-02-02

ApplicantMoe
Decision Date1989-02-02
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. is the device name listed in this FDA 510(k) record. The listed applicant is Moe. It received FDA 510(k) clearance on 1989-02-02 under 510(k) number K884852. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.?

BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. is a medical device that received FDA 510(k) clearance on 1989-02-02. The listed applicant is Moe. The 510(k) number is K884852.

When did BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. receive FDA 510(k) clearance?

BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. received FDA 510(k) clearance on 1989-02-02, under 510(k) number K884852.

Who is the listed applicant for BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.?

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

What is the FDA product code for BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.?

The FDA product code for BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI. is HCC.

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 Moe 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.

K884849BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BARK884851BIOFEEDBACK DEVICE TG3, TG4K884853BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1K884850BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30K884848BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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