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FDA 510(k)

RHINOTHERM ULTRA 2

K-Number: K894734 · 1990-02-16

ApplicantTwinmed Products, Inc.
Decision Date1990-02-16
Product CodeKFZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RHINOTHERM ULTRA 2 is the device name listed in this FDA 510(k) record. The listed applicant is Twinmed Products, Inc.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K894734. The device is classified under product code KFZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHINOTHERM ULTRA 2?

RHINOTHERM ULTRA 2 is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Twinmed Products, Inc.. The 510(k) number is K894734.

When did RHINOTHERM ULTRA 2 receive FDA 510(k) clearance?

RHINOTHERM ULTRA 2 received FDA 510(k) clearance on 1990-02-16, under 510(k) number K894734.

Who is the listed applicant for RHINOTHERM ULTRA 2?

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

What is the FDA product code for RHINOTHERM ULTRA 2?

The FDA product code for RHINOTHERM ULTRA 2 is KFZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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