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FDA 510(k)

NE-U07

K-Number: K922923 · 1992-09-15

ApplicantOmron Healthcare, Inc.
Decision Date1992-09-15
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NE-U07 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 1992-09-15 under 510(k) number K922923. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NE-U07?

NE-U07 is a medical device that received FDA 510(k) clearance on 1992-09-15. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K922923.

When did NE-U07 receive FDA 510(k) clearance?

NE-U07 received FDA 510(k) clearance on 1992-09-15, under 510(k) number K922923.

Who is the listed applicant for NE-U07?

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

What is the FDA product code for NE-U07?

The FDA product code for NE-U07 is CAF.

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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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