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FDA 510(k)

BRAIN MODULE RJ-Z10

K-Number: K830475 · 1983-06-08

ApplicantInstrumentation Industries, Inc.
Decision Date1983-06-08
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BRAIN MODULE RJ-Z10 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Industries, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K830475. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAIN MODULE RJ-Z10?

BRAIN MODULE RJ-Z10 is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Instrumentation Industries, Inc.. The 510(k) number is K830475.

When did BRAIN MODULE RJ-Z10 receive FDA 510(k) clearance?

BRAIN MODULE RJ-Z10 received FDA 510(k) clearance on 1983-06-08, under 510(k) number K830475.

Who is the listed applicant for BRAIN MODULE RJ-Z10?

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

What is the FDA product code for BRAIN MODULE RJ-Z10?

The FDA product code for BRAIN MODULE RJ-Z10 is CAI.

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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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