FDA 510(k)

VOLMETRIC COINCIDENCE DETECTION SYSTEM

K-Number: K962100 · 1997-01-10

Decision Date1997-01-10

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VOLMETRIC COINCIDENCE DETECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K962100. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLMETRIC COINCIDENCE DETECTION SYSTEM?

VOLMETRIC COINCIDENCE DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Elscint, Inc.. The 510(k) number is K962100.

When did VOLMETRIC COINCIDENCE DETECTION SYSTEM receive FDA 510(k) clearance?

VOLMETRIC COINCIDENCE DETECTION SYSTEM received FDA 510(k) clearance on 1997-01-10, under 510(k) number K962100.

Who is the listed applicant for VOLMETRIC COINCIDENCE DETECTION SYSTEM?

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

What is the FDA product code for VOLMETRIC COINCIDENCE DETECTION SYSTEM?

The FDA product code for VOLMETRIC COINCIDENCE DETECTION SYSTEM is KPS.

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Other records listing Elscint, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.