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FDA 510(k)

SI CONTROLLER MODEL SI 500

K-Number: K960492 · 1996-12-23

ApplicantI.C Medical, Inc.
Decision Date1996-12-23
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SI CONTROLLER MODEL SI 500 is the device name listed in this FDA 510(k) record. The listed applicant is I.C Medical, Inc.. It received FDA 510(k) clearance on 1996-12-23 under 510(k) number K960492. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SI CONTROLLER MODEL SI 500?

SI CONTROLLER MODEL SI 500 is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is I.C Medical, Inc.. The 510(k) number is K960492.

When did SI CONTROLLER MODEL SI 500 receive FDA 510(k) clearance?

SI CONTROLLER MODEL SI 500 received FDA 510(k) clearance on 1996-12-23, under 510(k) number K960492.

Who is the listed applicant for SI CONTROLLER MODEL SI 500?

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

What is the FDA product code for SI CONTROLLER MODEL SI 500?

The FDA product code for SI CONTROLLER MODEL SI 500 is BTA.

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Related Devices (Code: BTA)

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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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