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FDA 510(k)

THE REMOTE

K-Number: K912323 · 1991-09-06

ApplicantRemote Technologies, Inc.
Decision Date1991-09-06
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE REMOTE is the device name listed in this FDA 510(k) record. The listed applicant is Remote Technologies, Inc.. It received FDA 510(k) clearance on 1991-09-06 under 510(k) number K912323. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE REMOTE?

THE REMOTE is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Remote Technologies, Inc.. The 510(k) number is K912323.

When did THE REMOTE receive FDA 510(k) clearance?

THE REMOTE received FDA 510(k) clearance on 1991-09-06, under 510(k) number K912323.

Who is the listed applicant for THE REMOTE?

The FDA 510(k) record lists Remote Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE REMOTE?

The FDA product code for THE REMOTE is IZL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Remote Technologies, Inc. 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.

K801423RTM SYSTEM (REMOTE TEMPERATURE MONITOR)

Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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.

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