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FDA 510(k)

AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)

K-Number: K965006 · 1997-02-05

ApplicantStoelting Co.
Decision Date1997-02-05
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) is the device name listed in this FDA 510(k) record. The listed applicant is Stoelting Co.. It received FDA 510(k) clearance on 1997-02-05 under 510(k) number K965006. 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 AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)?

AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) is a medical device that received FDA 510(k) clearance on 1997-02-05. The listed applicant is Stoelting Co.. The 510(k) number is K965006.

When did AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) receive FDA 510(k) clearance?

AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) received FDA 510(k) clearance on 1997-02-05, under 510(k) number K965006.

Who is the listed applicant for AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)?

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

What is the FDA product code for AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)?

The FDA product code for AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) 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 Stoelting 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.

K012011MODIFICATION TO A620 EEGK952797AT53 DUAL CHANNEL EMGK944615A620 EEG

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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