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FDA 510(k)

DIFF 4 SYSTEM

K-Number: K830441 · 1983-05-16

ApplicantCoulter Electronics, Inc.
Decision Date1983-05-16
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIFF 4 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1983-05-16 under 510(k) number K830441. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIFF 4 SYSTEM?

DIFF 4 SYSTEM is a medical device that received FDA 510(k) clearance on 1983-05-16. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K830441.

When did DIFF 4 SYSTEM receive FDA 510(k) clearance?

DIFF 4 SYSTEM received FDA 510(k) clearance on 1983-05-16, under 510(k) number K830441.

Who is the listed applicant for DIFF 4 SYSTEM?

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

What is the FDA product code for DIFF 4 SYSTEM?

The FDA product code for DIFF 4 SYSTEM is EKZ.

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Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: EKZ)

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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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