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FDA 510(k)

MODIFICATION TO A620 EEG

K-Number: K012011 · 2001-10-10

ApplicantStoelting Co.
Decision Date2001-10-10
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO A620 EEG is the device name listed in this FDA 510(k) record. The listed applicant is Stoelting Co.. It received FDA 510(k) clearance on 2001-10-10 under 510(k) number K012011. 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 MODIFICATION TO A620 EEG?

MODIFICATION TO A620 EEG is a medical device that received FDA 510(k) clearance on 2001-10-10. The listed applicant is Stoelting Co.. The 510(k) number is K012011.

When did MODIFICATION TO A620 EEG receive FDA 510(k) clearance?

MODIFICATION TO A620 EEG received FDA 510(k) clearance on 2001-10-10, under 510(k) number K012011.

Who is the listed applicant for MODIFICATION TO A620 EEG?

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 MODIFICATION TO A620 EEG?

The FDA product code for MODIFICATION TO A620 EEG is HCC.

Related Clinical Trials

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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.

K965006AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)K952797AT53 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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