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FDA 510(k)

SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM

K-Number: K092713 · 2010-07-16

ApplicantTransamerican Medical Imaging
Decision Date2010-07-16
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Transamerican Medical Imaging. It received FDA 510(k) clearance on 2010-07-16 under 510(k) number K092713. 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 SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM?

SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-16. The listed applicant is Transamerican Medical Imaging. The 510(k) number is K092713.

When did SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM receive FDA 510(k) clearance?

SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM received FDA 510(k) clearance on 2010-07-16, under 510(k) number K092713.

Who is the listed applicant for SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM?

The FDA 510(k) record lists Transamerican Medical Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM?

The FDA product code for SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM is IZL.

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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

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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