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FDA 510(k)

RUSCH ENDOTEST CUFF PRESSURE MONITOR

K-Number: K951046 · 1995-04-06

ApplicantRusch Intl.
Decision Date1995-04-06
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RUSCH ENDOTEST CUFF PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Rusch Intl.. It received FDA 510(k) clearance on 1995-04-06 under 510(k) number K951046. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUSCH ENDOTEST CUFF PRESSURE MONITOR?

RUSCH ENDOTEST CUFF PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Rusch Intl.. The 510(k) number is K951046.

When did RUSCH ENDOTEST CUFF PRESSURE MONITOR receive FDA 510(k) clearance?

RUSCH ENDOTEST CUFF PRESSURE MONITOR received FDA 510(k) clearance on 1995-04-06, under 510(k) number K951046.

Who is the listed applicant for RUSCH ENDOTEST CUFF PRESSURE MONITOR?

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 ENDOTEST CUFF PRESSURE MONITOR?

The FDA product code for RUSCH ENDOTEST CUFF PRESSURE MONITOR is BSK.

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Other records listing Rusch Intl. as applicant

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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: BSK)

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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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