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FDA 510(k)

CADENCE II

K-Number: K073221 · 2007-12-28

ApplicantEdan Instruments, Inc.
Decision Date2007-12-28
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CADENCE II is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2007-12-28 under 510(k) number K073221. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CADENCE II?

CADENCE II is a medical device that received FDA 510(k) clearance on 2007-12-28. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K073221.

When did CADENCE II receive FDA 510(k) clearance?

CADENCE II received FDA 510(k) clearance on 2007-12-28, under 510(k) number K073221.

Who is the listed applicant for CADENCE II?

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

What is the FDA product code for CADENCE II?

The FDA product code for CADENCE II is HGM.

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Other records listing Edan Instruments, Inc. as applicant

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Related Devices (Code: HGM)

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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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