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FDA 510(k)

CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR

K-Number: K902114 · 1990-07-18

ApplicantDiemolding Corp.
Decision Date1990-07-18
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Diemolding Corp.. It received FDA 510(k) clearance on 1990-07-18 under 510(k) number K902114. 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 CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR?

CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR is a medical device that received FDA 510(k) clearance on 1990-07-18. The listed applicant is Diemolding Corp.. The 510(k) number is K902114.

When did CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR receive FDA 510(k) clearance?

CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR received FDA 510(k) clearance on 1990-07-18, under 510(k) number K902114.

Who is the listed applicant for CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR?

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

What is the FDA product code for CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR?

The FDA product code for CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR is BSK.

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Other records listing Diemolding Corp. as applicant

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K962749THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORTK961455MEDSHIELD/AEROCHAMBERK902713ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANSK900754RESPIREX 2K893791BREATHING MOUTHPIECEK781759RESCAL

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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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