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FDA 510(k)

CASE 12

K-Number: K862316 · 1986-11-20

ApplicantMarquette Electronics, Inc.
Decision Date1986-11-20
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CASE 12 is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1986-11-20 under 510(k) number K862316. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASE 12?

CASE 12 is a medical device that received FDA 510(k) clearance on 1986-11-20. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K862316.

When did CASE 12 receive FDA 510(k) clearance?

CASE 12 received FDA 510(k) clearance on 1986-11-20, under 510(k) number K862316.

Who is the listed applicant for CASE 12?

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

What is the FDA product code for CASE 12?

The FDA product code for CASE 12 is DSI.

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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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