FDA 510(k)

SIM-400 SYSTEM

K-Number: K931193 · 1993-06-21

Decision Date1993-06-21

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SIM-400 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scinticor, Inc.. It received FDA 510(k) clearance on 1993-06-21 under 510(k) number K931193. 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 SIM-400 SYSTEM?

SIM-400 SYSTEM is a medical device that received FDA 510(k) clearance on 1993-06-21. The listed applicant is Scinticor, Inc.. The 510(k) number is K931193.

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

SIM-400 SYSTEM received FDA 510(k) clearance on 1993-06-21, under 510(k) number K931193.

Who is the listed applicant for SIM-400 SYSTEM?

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

What is the FDA product code for SIM-400 SYSTEM?

The FDA product code for SIM-400 SYSTEM is KPS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Scinticor, Inc. as applicant

K885054SYSTEM SEVENTY SEVEN

Related Devices (Code: KPS)

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.