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FDA 510(k)

OMNIMED SUPERIOR TRANSDUCER PROTECTOR

K-Number: K851734 · 1985-05-23

ApplicantOmni Intl., Inc.
Decision Date1985-05-23
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNIMED SUPERIOR TRANSDUCER PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Omni Intl., Inc.. It received FDA 510(k) clearance on 1985-05-23 under 510(k) number K851734. 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 OMNIMED SUPERIOR TRANSDUCER PROTECTOR?

OMNIMED SUPERIOR TRANSDUCER PROTECTOR is a medical device that received FDA 510(k) clearance on 1985-05-23. The listed applicant is Omni Intl., Inc.. The 510(k) number is K851734.

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

OMNIMED SUPERIOR TRANSDUCER PROTECTOR received FDA 510(k) clearance on 1985-05-23, under 510(k) number K851734.

Who is the listed applicant for OMNIMED SUPERIOR TRANSDUCER PROTECTOR?

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

What is the FDA product code for OMNIMED SUPERIOR TRANSDUCER PROTECTOR?

The FDA product code for OMNIMED SUPERIOR TRANSDUCER PROTECTOR is FIB.

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Other records listing Omni Intl., 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.

K984066OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIMK984064OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREEK853255OMNIMED I.V. SOLUTION ADMIN. SETK851938OMNIMED SURGICAL GOWNK851654OMNIMED CLAMPK850706F-SERIES IMPLANT

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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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