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FDA 510(k)

US-1000 ULTRASONIC IMAGING SYSTEM

K-Number: K832331 · 1983-08-16

ApplicantNidek, Inc.
Decision Date1983-08-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

US-1000 ULTRASONIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K832331. 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 US-1000 ULTRASONIC IMAGING SYSTEM?

US-1000 ULTRASONIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Nidek, Inc.. The 510(k) number is K832331.

When did US-1000 ULTRASONIC IMAGING SYSTEM receive FDA 510(k) clearance?

US-1000 ULTRASONIC IMAGING SYSTEM received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832331.

Who is the listed applicant for US-1000 ULTRASONIC IMAGING SYSTEM?

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

What is the FDA product code for US-1000 ULTRASONIC IMAGING SYSTEM?

The FDA product code for US-1000 ULTRASONIC IMAGING SYSTEM is IYO.

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Other records listing Nidek, Inc. as applicant

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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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