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FDA 510(k)

DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR

K-Number: K011070 · 2001-11-07

ApplicantMoor Instruments, Ltd.
Decision Date2001-11-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR 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 2001-11-07 under 510(k) number K011070. 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 DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR?

DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR is a medical device that received FDA 510(k) clearance on 2001-11-07. The listed applicant is Moor Instruments, Ltd.. The 510(k) number is K011070.

When did DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR receive FDA 510(k) clearance?

DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR received FDA 510(k) clearance on 2001-11-07, under 510(k) number K011070.

Who is the listed applicant for DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR?

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 DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR?

The FDA product code for DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR is GEX. This falls under the Gastroenterology category.

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Other records listing Moor Instruments, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imagerK122943MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGERK112826NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITORK102433MOORVMS-PRES PRESSURE CUFF CONTROLLERK083082MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORSK060976MOORLD12-B1 LASER DOPPLER BURNS IMAGER

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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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