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FDA 510(k)

ULTRATONE 8+ & 20

K-Number: K926410 · 1993-08-11

ApplicantBowater Research, Inc.
Decision Date1993-08-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRATONE 8+ & 20 is the device name listed in this FDA 510(k) record. The listed applicant is Bowater Research, Inc.. It received FDA 510(k) clearance on 1993-08-11 under 510(k) number K926410. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRATONE 8+ & 20?

ULTRATONE 8+ & 20 is a medical device that received FDA 510(k) clearance on 1993-08-11. The listed applicant is Bowater Research, Inc.. The 510(k) number is K926410.

When did ULTRATONE 8+ & 20 receive FDA 510(k) clearance?

ULTRATONE 8+ & 20 received FDA 510(k) clearance on 1993-08-11, under 510(k) number K926410.

Who is the listed applicant for ULTRATONE 8+ & 20?

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

What is the FDA product code for ULTRATONE 8+ & 20?

The FDA product code for ULTRATONE 8+ & 20 is IPF.

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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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