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FDA 510(k)

ISOLA TWISTER CONNECTOR

K-Number: K965046 · 1997-03-14

ApplicantAcromed Corp.
Decision Date1997-03-14
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ISOLA TWISTER CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Acromed Corp.. It received FDA 510(k) clearance on 1997-03-14 under 510(k) number K965046. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ISOLA TWISTER CONNECTOR?

ISOLA TWISTER CONNECTOR is a medical device that received FDA 510(k) clearance on 1997-03-14. The listed applicant is Acromed Corp.. The 510(k) number is K965046.

When did ISOLA TWISTER CONNECTOR receive FDA 510(k) clearance?

ISOLA TWISTER CONNECTOR received FDA 510(k) clearance on 1997-03-14, under 510(k) number K965046.

Who is the listed applicant for ISOLA TWISTER CONNECTOR?

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

What is the FDA product code for ISOLA TWISTER CONNECTOR?

The FDA product code for ISOLA TWISTER CONNECTOR is MNH. This falls under the ENT category.

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Other records listing Acromed Corp. as applicant

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Related Devices (Code: MNH)

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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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