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FDA 510(k)

ULTRACAM

K-Number: K973410 · 1998-10-08

ApplicantW. Edward Johansen
Decision Date1998-10-08
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRACAM is the device name listed in this FDA 510(k) record. The listed applicant is W. Edward Johansen. It received FDA 510(k) clearance on 1998-10-08 under 510(k) number K973410. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACAM?

ULTRACAM is a medical device that received FDA 510(k) clearance on 1998-10-08. The listed applicant is W. Edward Johansen. The 510(k) number is K973410.

When did ULTRACAM receive FDA 510(k) clearance?

ULTRACAM received FDA 510(k) clearance on 1998-10-08, under 510(k) number K973410.

Who is the listed applicant for ULTRACAM?

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

What is the FDA product code for ULTRACAM?

The FDA product code for ULTRACAM is EIA.

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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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