FDA 510(k)

MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS

K-Number: K083082 · 2009-01-13

Decision Date2009-01-13

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS is the device name listed in this FDA 510(k) record. The listed applicant is Moor Instruments, Ltd.. It received FDA 510(k) clearance on 2009-01-13 under 510(k) number K083082. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS?

MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS is a medical device that received FDA 510(k) clearance on 2009-01-13. The listed applicant is Moor Instruments, Ltd.. The 510(k) number is K083082.

When did MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS receive FDA 510(k) clearance?

MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS received FDA 510(k) clearance on 2009-01-13, under 510(k) number K083082.

Who is the listed applicant for MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS?

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

What is the FDA product code for MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS?

The FDA product code for MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS is GEX. This falls under the Gastroenterology category.

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Other records listing Moor Instruments, Ltd. as applicant

K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager K122943MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER K112826NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR K102433MOORVMS-PRES PRESSURE CUFF CONTROLLER K060976MOORLD12-B1 LASER DOPPLER BURNS IMAGER K063586MOORFLPI FULL-FIELD LASER PERFUSION IMAGER

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.