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FDA 510(k)

PRESTODR PORTABLE

K-Number: K100400 · 2010-04-22

ApplicantCmt Medical Technologies, Ltd.
Decision Date2010-04-22
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRESTODR PORTABLE is the device name listed in this FDA 510(k) record. The listed applicant is Cmt Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2010-04-22 under 510(k) number K100400. 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 PRESTODR PORTABLE?

PRESTODR PORTABLE is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is Cmt Medical Technologies, Ltd.. The 510(k) number is K100400.

When did PRESTODR PORTABLE receive FDA 510(k) clearance?

PRESTODR PORTABLE received FDA 510(k) clearance on 2010-04-22, under 510(k) number K100400.

Who is the listed applicant for PRESTODR PORTABLE?

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

What is the FDA product code for PRESTODR PORTABLE?

The FDA product code for PRESTODR PORTABLE is IZL.

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Other records listing Cmt Medical Technologies, 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.

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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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