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FDA 510(k)

MEDISYSTEMS TRANDUCER PROTECTOR

K-Number: K970536 · 1997-05-12

ApplicantMedisystems Corp.
Decision Date1997-05-12
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDISYSTEMS TRANDUCER PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medisystems Corp.. It received FDA 510(k) clearance on 1997-05-12 under 510(k) number K970536. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDISYSTEMS TRANDUCER PROTECTOR?

MEDISYSTEMS TRANDUCER PROTECTOR is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Medisystems Corp.. The 510(k) number is K970536.

When did MEDISYSTEMS TRANDUCER PROTECTOR receive FDA 510(k) clearance?

MEDISYSTEMS TRANDUCER PROTECTOR received FDA 510(k) clearance on 1997-05-12, under 510(k) number K970536.

Who is the listed applicant for MEDISYSTEMS TRANDUCER PROTECTOR?

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

What is the FDA product code for MEDISYSTEMS TRANDUCER PROTECTOR?

The FDA product code for MEDISYSTEMS TRANDUCER PROTECTOR is FIB.

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Other records listing Medisystems Corp. 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.

K062953MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICEK010279MEDISYSTEMS LUER ACCESS INJECTION SITEK002372ACCESS ALERT GAUGEK994306REVERSOK990803MEDISYSTEMS BUTTONHOLE NEEDLE SETSK983076MEDISYSTEMS TRANSDUCER PROTECTOR

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Related Devices (Code: FIB)

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.

K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1Nipro Medical CorporationK001971HEMODIALYSIS TUBING SETSOfi Biomedica S.P.A.K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2Fresenius Medical Care North America

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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