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FDA 510(k)

M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000

K-Number: K100046 · 2010-04-08

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2010-04-08
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2010-04-08 under 510(k) number K100046. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000?

M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 is a medical device that received FDA 510(k) clearance on 2010-04-08. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K100046.

When did M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 receive FDA 510(k) clearance?

M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 received FDA 510(k) clearance on 2010-04-08, under 510(k) number K100046.

Who is the listed applicant for M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000?

The FDA 510(k) record lists Guangdong Biolight Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000?

The FDA product code for M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 is MHX.

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Other records listing Guangdong Biolight Meditech Co., Ltd. as applicant

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Related Devices (Code: MHX)

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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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