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FDA 510(k)

ULTRACALM

K-Number: K910625 · 1992-05-15

ApplicantSion Technology, Inc.
Decision Date1992-05-15
Product CodeLWM
DecisionSubstantially Equivalent

Device Summary

ULTRACALM is the device name listed in this FDA 510(k) record. The listed applicant is Sion Technology, Inc.. It received FDA 510(k) clearance on 1992-05-15 under 510(k) number K910625. The device is classified under product code LWM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACALM?

ULTRACALM is a medical device that received FDA 510(k) clearance on 1992-05-15. The listed applicant is Sion Technology, Inc.. The 510(k) number is K910625.

When did ULTRACALM receive FDA 510(k) clearance?

ULTRACALM received FDA 510(k) clearance on 1992-05-15, under 510(k) number K910625.

Who is the listed applicant for ULTRACALM?

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

What is the FDA product code for ULTRACALM?

The FDA product code for ULTRACALM is LWM.

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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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