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FDA 510(k)

AT53 DUAL CHANNEL EMG

K-Number: K952797 · 1996-04-17

ApplicantStoelting Co.
Decision Date1996-04-17
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AT53 DUAL CHANNEL EMG is the device name listed in this FDA 510(k) record. The listed applicant is Stoelting Co.. It received FDA 510(k) clearance on 1996-04-17 under 510(k) number K952797. 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 AT53 DUAL CHANNEL EMG?

AT53 DUAL CHANNEL EMG is a medical device that received FDA 510(k) clearance on 1996-04-17. The listed applicant is Stoelting Co.. The 510(k) number is K952797.

When did AT53 DUAL CHANNEL EMG receive FDA 510(k) clearance?

AT53 DUAL CHANNEL EMG received FDA 510(k) clearance on 1996-04-17, under 510(k) number K952797.

Who is the listed applicant for AT53 DUAL CHANNEL EMG?

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 AT53 DUAL CHANNEL EMG?

The FDA product code for AT53 DUAL CHANNEL EMG is HCC.

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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.

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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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