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FDA 510(k)

SIS Software Version 3.6.0

K-Number: K192304 · 2019-09-13

ApplicantSurgical Information Sciences, Inc.
Decision Date2019-09-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIS Software Version 3.6.0 is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Information Sciences, Inc.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K192304. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIS Software Version 3.6.0?

SIS Software Version 3.6.0 is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Surgical Information Sciences, Inc.. The 510(k) number is K192304.

When did SIS Software Version 3.6.0 receive FDA 510(k) clearance?

SIS Software Version 3.6.0 received FDA 510(k) clearance on 2019-09-13, under 510(k) number K192304.

Who is the listed applicant for SIS Software Version 3.6.0?

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

What is the FDA product code for SIS Software Version 3.6.0?

The FDA product code for SIS Software Version 3.6.0 is LLZ.

Other records listing Surgical Information Sciences, Inc. as applicant

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.

K241083SIS SystemK230977SIS SystemK223032SIS System (Version 5.6.0)K210071SIS System (Version 5.1.0)K183019SIS Software version 3.3.0K162830SIS Software

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Related Devices (Code: LLZ)

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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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