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FDA 510(k)

GENERAL ELECTRIC AMX II

K-Number: K891142 · 1989-05-01

ApplicantPro-Tronics, Inc.
Decision Date1989-05-01
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENERAL ELECTRIC AMX II is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Tronics, Inc.. It received FDA 510(k) clearance on 1989-05-01 under 510(k) number K891142. 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 GENERAL ELECTRIC AMX II?

GENERAL ELECTRIC AMX II is a medical device that received FDA 510(k) clearance on 1989-05-01. The listed applicant is Pro-Tronics, Inc.. The 510(k) number is K891142.

When did GENERAL ELECTRIC AMX II receive FDA 510(k) clearance?

GENERAL ELECTRIC AMX II received FDA 510(k) clearance on 1989-05-01, under 510(k) number K891142.

Who is the listed applicant for GENERAL ELECTRIC AMX II?

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

What is the FDA product code for GENERAL ELECTRIC AMX II?

The FDA product code for GENERAL ELECTRIC AMX II 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.

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Other records listing Pro-Tronics, 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.

K950971MOBIL C-ARM, REGURBISHED, VARIOUS MODELSK944442GENERAL ELECTRIC AMX 110, AMX II AND AMX 3K902610GENERAL ELECTRIC AMX 3K891143GENERAL ELECTRIC AMX 110

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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