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FDA 510(k)

CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR

K-Number: K082369 · 2008-11-07

ApplicantEdan Instruments, Inc.
Decision Date2008-11-07
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR 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 2008-11-07 under 510(k) number K082369. 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, CADENCE DUAL, CADENCE II FETAL MONITOR?

CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K082369.

When did CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR receive FDA 510(k) clearance?

CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082369.

Who is the listed applicant for CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR?

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, CADENCE DUAL, CADENCE II FETAL MONITOR?

The FDA product code for CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR is HGM.

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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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