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FDA 510(k)

C/PES 9103, ECG STRESS TESTING SYSTEM

K-Number: K850113 · 1985-02-08

ApplicantGould, Inc.
Decision Date1985-02-08
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

C/PES 9103, ECG STRESS TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1985-02-08 under 510(k) number K850113. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C/PES 9103, ECG STRESS TESTING SYSTEM?

C/PES 9103, ECG STRESS TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1985-02-08. The listed applicant is Gould, Inc.. The 510(k) number is K850113.

When did C/PES 9103, ECG STRESS TESTING SYSTEM receive FDA 510(k) clearance?

C/PES 9103, ECG STRESS TESTING SYSTEM received FDA 510(k) clearance on 1985-02-08, under 510(k) number K850113.

Who is the listed applicant for C/PES 9103, ECG STRESS TESTING SYSTEM?

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

What is the FDA product code for C/PES 9103, ECG STRESS TESTING SYSTEM?

The FDA product code for C/PES 9103, ECG STRESS TESTING SYSTEM is DRT.

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Other records listing Gould, Inc. 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.

K911935CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIEDK861092MODEL SP1465 CARDIAC OUTPUT COMPUTERK860805PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORK854403MODEL 2120 SPIROSCREENK851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

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Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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