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FDA 510(k)

ULTRA COM

K-Number: K812209 · 1981-11-16

ApplicantUltranamics, Inc.
Decision Date1981-11-16
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRA COM is the device name listed in this FDA 510(k) record. The listed applicant is Ultranamics, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812209. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA COM?

ULTRA COM is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Ultranamics, Inc.. The 510(k) number is K812209.

When did ULTRA COM receive FDA 510(k) clearance?

ULTRA COM received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812209.

Who is the listed applicant for ULTRA COM?

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

What is the FDA product code for ULTRA COM?

The FDA product code for ULTRA COM is DXK.

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Related Devices (Code: DXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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