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FDA 510(k)

MODELS TA 1017 & 1017T GRITIFLO DISPOS

K-Number: K811538 · 1981-06-12

ApplicantGould, Inc.
Decision Date1981-06-12
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODELS TA 1017 & 1017T GRITIFLO DISPOS is the device name listed in this FDA 510(k) record. The listed applicant is Gould, Inc.. It received FDA 510(k) clearance on 1981-06-12 under 510(k) number K811538. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS TA 1017 & 1017T GRITIFLO DISPOS?

MODELS TA 1017 & 1017T GRITIFLO DISPOS is a medical device that received FDA 510(k) clearance on 1981-06-12. The listed applicant is Gould, Inc.. The 510(k) number is K811538.

When did MODELS TA 1017 & 1017T GRITIFLO DISPOS receive FDA 510(k) clearance?

MODELS TA 1017 & 1017T GRITIFLO DISPOS received FDA 510(k) clearance on 1981-06-12, under 510(k) number K811538.

Who is the listed applicant for MODELS TA 1017 & 1017T GRITIFLO DISPOS?

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 MODELS TA 1017 & 1017T GRITIFLO DISPOS?

The FDA product code for MODELS TA 1017 & 1017T GRITIFLO DISPOS is DRS.

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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: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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