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FDA 510(k)

SCM-400 HOLTER SYSTEM

K-Number: K860950 · 1986-05-02

ApplicantFukuda Denshi USA, Inc.
Decision Date1986-05-02
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCM-400 HOLTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K860950. 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 SCM-400 HOLTER SYSTEM?

SCM-400 HOLTER SYSTEM is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K860950.

When did SCM-400 HOLTER SYSTEM receive FDA 510(k) clearance?

SCM-400 HOLTER SYSTEM received FDA 510(k) clearance on 1986-05-02, under 510(k) number K860950.

Who is the listed applicant for SCM-400 HOLTER SYSTEM?

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

What is the FDA product code for SCM-400 HOLTER SYSTEM?

The FDA product code for SCM-400 HOLTER SYSTEM 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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