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FDA 510(k)

ULTRA WAVE 101

K-Number: K905836 · 1991-01-14

ApplicantAko USA, Inc.
Decision Date1991-01-14
Product CodeIRO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRA WAVE 101 is the device name listed in this FDA 510(k) record. The listed applicant is Ako USA, Inc.. It received FDA 510(k) clearance on 1991-01-14 under 510(k) number K905836. The device is classified under product code IRO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA WAVE 101?

ULTRA WAVE 101 is a medical device that received FDA 510(k) clearance on 1991-01-14. The listed applicant is Ako USA, Inc.. The 510(k) number is K905836.

When did ULTRA WAVE 101 receive FDA 510(k) clearance?

ULTRA WAVE 101 received FDA 510(k) clearance on 1991-01-14, under 510(k) number K905836.

Who is the listed applicant for ULTRA WAVE 101?

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

What is the FDA product code for ULTRA WAVE 101?

The FDA product code for ULTRA WAVE 101 is IRO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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