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FDA 510(k)

RUSCH OPTOSAFE

K-Number: K960240 · 1996-04-19

ApplicantRusch Intl.
Decision Date1996-04-19
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RUSCH OPTOSAFE is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 1996-04-19 under 510(k) number K960240. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH OPTOSAFE?

RUSCH OPTOSAFE is a medical device that received FDA 510(k) clearance on 1996-04-19. The listed applicant is Rusch Intl.. The 510(k) number is K960240.

When did RUSCH OPTOSAFE receive FDA 510(k) clearance?

RUSCH OPTOSAFE received FDA 510(k) clearance on 1996-04-19, under 510(k) number K960240.

Who is the listed applicant for RUSCH OPTOSAFE?

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

What is the FDA product code for RUSCH OPTOSAFE?

The FDA product code for RUSCH OPTOSAFE is CAE.

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Other records listing Rusch 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.

K033023INTERMITTENT URETHRAL CATHETERSK030559RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEMK023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETERK023918RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESSK023964RUSCH MICROLARYNGEAL TUBEK021540RUSCH EDGAR TUBE

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Related Devices (Code: CAE)

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.

K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305King Systems Corp.K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205King Systems Corp.K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp.K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)Mallinckrodt MedicalK950613KEISEIKeisei (Usa) Co., Ltd.K953400GUEDEL AIRWAYMallinckrodt Medical

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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