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FDA 510(k)

ULTRASOUND SCANNER MODEL #1150

K-Number: K900469 · 1990-07-09

ApplicantPie Medical USA BV
Decision Date1990-07-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER MODEL #1150 is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical USA BV. It received FDA 510(k) clearance on 1990-07-09 under 510(k) number K900469. 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 ULTRASOUND SCANNER MODEL #1150?

ULTRASOUND SCANNER MODEL #1150 is a medical device that received FDA 510(k) clearance on 1990-07-09. The listed applicant is Pie Medical USA BV. The 510(k) number is K900469.

When did ULTRASOUND SCANNER MODEL #1150 receive FDA 510(k) clearance?

ULTRASOUND SCANNER MODEL #1150 received FDA 510(k) clearance on 1990-07-09, under 510(k) number K900469.

Who is the listed applicant for ULTRASOUND SCANNER MODEL #1150?

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

What is the FDA product code for ULTRASOUND SCANNER MODEL #1150?

The FDA product code for ULTRASOUND SCANNER MODEL #1150 is IYO.

Related Clinical Trials

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Other records listing Pie Medical USA BV 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.

K880580EXTENDED MULTIPURPOSE TRANSDUCER RANGE

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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