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FDA 510(k)

EMG 3510/EMG 3510D MYOFEEDBACK MONITORS

K-Number: K810881 · 1981-05-27

ApplicantAtlas Researches , Ltd.
Decision Date1981-05-27
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EMG 3510/EMG 3510D MYOFEEDBACK MONITORS is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Researches , Ltd.. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K810881. 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 EMG 3510/EMG 3510D MYOFEEDBACK MONITORS?

EMG 3510/EMG 3510D MYOFEEDBACK MONITORS is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Atlas Researches , Ltd.. The 510(k) number is K810881.

When did EMG 3510/EMG 3510D MYOFEEDBACK MONITORS receive FDA 510(k) clearance?

EMG 3510/EMG 3510D MYOFEEDBACK MONITORS received FDA 510(k) clearance on 1981-05-27, under 510(k) number K810881.

Who is the listed applicant for EMG 3510/EMG 3510D MYOFEEDBACK MONITORS?

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

What is the FDA product code for EMG 3510/EMG 3510D MYOFEEDBACK MONITORS?

The FDA product code for EMG 3510/EMG 3510D MYOFEEDBACK MONITORS is HCC.

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Other records listing Atlas Researches , Ltd. 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.

K8627478800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORSK810880AR-1 PHYSIOLOGICAL PRODESSORK810882ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A

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

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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