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FDA 510(k)

ULTRAMIST 2000

K-Number: K972657 · 1998-02-02

ApplicantTexas Medical Industries, Inc.
Decision Date1998-02-02
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ULTRAMIST 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medical Industries, Inc.. It received FDA 510(k) clearance on 1998-02-02 under 510(k) number K972657. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAMIST 2000?

ULTRAMIST 2000 is a medical device that received FDA 510(k) clearance on 1998-02-02. The listed applicant is Texas Medical Industries, Inc.. The 510(k) number is K972657.

When did ULTRAMIST 2000 receive FDA 510(k) clearance?

ULTRAMIST 2000 received FDA 510(k) clearance on 1998-02-02, under 510(k) number K972657.

Who is the listed applicant for ULTRAMIST 2000?

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

What is the FDA product code for ULTRAMIST 2000?

The FDA product code for ULTRAMIST 2000 is CAF.

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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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