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FDA 510(k)

ORION DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K930768 · 1994-03-15

ApplicantGE Medical Systems
Decision Date1994-03-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORION DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1994-03-15 under 510(k) number K930768. 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 ORION DIAGNOSTIC ULTRASOUND SYSTEM?

ORION DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-15. The listed applicant is GE Medical Systems. The 510(k) number is K930768.

When did ORION DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ORION DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 1994-03-15, under 510(k) number K930768.

Who is the listed applicant for ORION DIAGNOSTIC ULTRASOUND SYSTEM?

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

What is the FDA product code for ORION DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for ORION DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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Other records listing GE Medical Systems as applicant

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Related Devices (Code: IYO)

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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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