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FDA 510(k)

MEDIFLEX TRANSDUCER PROTECTOR

K-Number: K863496 · 1986-09-23

ApplicantMediflex Intl.
Decision Date1986-09-23
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDIFLEX TRANSDUCER PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Mediflex Intl.. It received FDA 510(k) clearance on 1986-09-23 under 510(k) number K863496. 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 MEDIFLEX TRANSDUCER PROTECTOR?

MEDIFLEX TRANSDUCER PROTECTOR is a medical device that received FDA 510(k) clearance on 1986-09-23. The listed applicant is Mediflex Intl.. The 510(k) number is K863496.

When did MEDIFLEX TRANSDUCER PROTECTOR receive FDA 510(k) clearance?

MEDIFLEX TRANSDUCER PROTECTOR received FDA 510(k) clearance on 1986-09-23, under 510(k) number K863496.

Who is the listed applicant for MEDIFLEX TRANSDUCER PROTECTOR?

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

What is the FDA product code for MEDIFLEX TRANSDUCER PROTECTOR?

The FDA product code for MEDIFLEX TRANSDUCER PROTECTOR is FIB.

Related Clinical Trials

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Other records listing Mediflex Intl. 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.

K915140PRIMARY DRESSING TRAYK900841HEMODIALYSIS TRANSDUCER PROTECTORK891077MEDIVERSE PARENTERAL NUTRITION BAGK884243BLOOD TUBING SETK855039MEDIFLEX INJECTION CAPK854346MEDIFLEX DISPOSABLE TUBING CLAMP

View all 9 devices →

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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