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FDA 510(k)

VITAL SIGNS MONITOR MODEL M3B

K-Number: K101539 · 2010-11-24

ApplicantEdan Instruments, Inc.
Decision Date2010-11-24
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL SIGNS MONITOR MODEL M3B 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 2010-11-24 under 510(k) number K101539. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SIGNS MONITOR MODEL M3B?

VITAL SIGNS MONITOR MODEL M3B is a medical device that received FDA 510(k) clearance on 2010-11-24. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K101539.

When did VITAL SIGNS MONITOR MODEL M3B receive FDA 510(k) clearance?

VITAL SIGNS MONITOR MODEL M3B received FDA 510(k) clearance on 2010-11-24, under 510(k) number K101539.

Who is the listed applicant for VITAL SIGNS MONITOR MODEL M3B?

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 VITAL SIGNS MONITOR MODEL M3B?

The FDA product code for VITAL SIGNS MONITOR MODEL M3B is DQA.

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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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