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FDA 510(k)

HAND HELD DENTAL X-RAY DEVICE

K-Number: K934818 · 1994-01-24

ApplicantDept. of the Army
Decision Date1994-01-24
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HAND HELD DENTAL X-RAY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Dept. of the Army. It received FDA 510(k) clearance on 1994-01-24 under 510(k) number K934818. 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 HAND HELD DENTAL X-RAY DEVICE?

HAND HELD DENTAL X-RAY DEVICE is a medical device that received FDA 510(k) clearance on 1994-01-24. The listed applicant is Dept. of the Army. The 510(k) number is K934818.

When did HAND HELD DENTAL X-RAY DEVICE receive FDA 510(k) clearance?

HAND HELD DENTAL X-RAY DEVICE received FDA 510(k) clearance on 1994-01-24, under 510(k) number K934818.

Who is the listed applicant for HAND HELD DENTAL X-RAY DEVICE?

The FDA 510(k) record lists Dept. of the Army as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAND HELD DENTAL X-RAY DEVICE?

The FDA product code for HAND HELD DENTAL X-RAY DEVICE is IZL.

Related Clinical Trials

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Other records listing Dept. of the Army 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.

K023969REACTIVE SKIN DECONTAMINATION LOTIONK921613STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510K901760LITTER, FOLDING RIGID POLE, DECONTAMINABLEK894455DECONTAMINATING KIT, SKIN: M291

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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