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FDA 510(k)

DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000

K-Number: K850580 · 1985-04-03

ApplicantElscint, Inc.
Decision Date1985-04-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1985-04-03 under 510(k) number K850580. 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 DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000?

DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 is a medical device that received FDA 510(k) clearance on 1985-04-03. The listed applicant is Elscint, Inc.. The 510(k) number is K850580.

When did DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 receive FDA 510(k) clearance?

DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 received FDA 510(k) clearance on 1985-04-03, under 510(k) number K850580.

Who is the listed applicant for DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000?

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

What is the FDA product code for DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000?

The FDA product code for DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 is IYO.

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Other records listing Elscint, Inc. 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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