FDA 510(k)

CUSIS ULTRASOUND SKIN IMAGING SYSTEM

K-Number: K893996 · 1989-09-21

ApplicantStiefel Research Institute, Inc.

Decision Date1989-09-21

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CUSIS ULTRASOUND SKIN IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stiefel Research Institute, Inc.. It received FDA 510(k) clearance on 1989-09-21 under 510(k) number K893996. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSIS ULTRASOUND SKIN IMAGING SYSTEM?

CUSIS ULTRASOUND SKIN IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-21. The listed applicant is Stiefel Research Institute, Inc.. The 510(k) number is K893996.

When did CUSIS ULTRASOUND SKIN IMAGING SYSTEM receive FDA 510(k) clearance?

CUSIS ULTRASOUND SKIN IMAGING SYSTEM received FDA 510(k) clearance on 1989-09-21, under 510(k) number K893996.

Who is the listed applicant for CUSIS ULTRASOUND SKIN IMAGING SYSTEM?

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

What is the FDA product code for CUSIS ULTRASOUND SKIN IMAGING SYSTEM?

The FDA product code for CUSIS ULTRASOUND SKIN IMAGING SYSTEM is IYO.

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Official Source

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