FDA 510(k)

INVOTEC EAR DRAPE

K-Number: K911039 · 1991-05-13

Decision Date1991-05-13

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

INVOTEC EAR DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Invotec International, Inc.. It received FDA 510(k) clearance on 1991-05-13 under 510(k) number K911039. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVOTEC EAR DRAPE?

INVOTEC EAR DRAPE is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is Invotec International, Inc.. The 510(k) number is K911039.

When did INVOTEC EAR DRAPE receive FDA 510(k) clearance?

INVOTEC EAR DRAPE received FDA 510(k) clearance on 1991-05-13, under 510(k) number K911039.

Who is the listed applicant for INVOTEC EAR DRAPE?

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

What is the FDA product code for INVOTEC EAR DRAPE?

The FDA product code for INVOTEC EAR DRAPE is KKX.

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Other records listing Invotec International, Inc. as applicant

K122040INVOTEC LARYNGEAL ELECTRODE K080740CLEARVIEW ENDOSCOPE COVER K030492TITANIUM OSSICULAR REPLACMENT SYSTEM K973580INVOTEC CLEAN PAD K973578INVOTEC EAR TAMPON (WICK) W/STRING K971000EPISTAXIS NASAL PACK

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Related Devices (Code: KKX)

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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.