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FDA 510(k)

ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER

K-Number: K121243 · 2013-05-03

ApplicantMEDA Co., Ltd.
Decision Date2013-05-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER is the device name listed in this FDA 510(k) record. The listed applicant is MEDA Co., Ltd.. It received FDA 510(k) clearance on 2013-05-03 under 510(k) number K121243. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER?

ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER is a medical device that received FDA 510(k) clearance on 2013-05-03. The listed applicant is MEDA Co., Ltd.. The 510(k) number is K121243.

When did ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER receive FDA 510(k) clearance?

ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER received FDA 510(k) clearance on 2013-05-03, under 510(k) number K121243.

Who is the listed applicant for ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER?

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

What is the FDA product code for ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER?

The FDA product code for ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER is IYO.

Related Clinical Trials

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Other records listing MEDA Co., 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.

K260313MD-6000S Bladder ScannerK213070MD-320W Ultrasound BiomicroscopeK182460MD-6000P Bladder ScannerK113304BLADDER SCANNER

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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