Sinuscan 102/SINUSPRINT

FDA 510(k) K960421 · Ferguson Medical

Substantially Equivalent

510(k) numberK960421

Submission

Device name
Sinuscan 102/SINUSPRINT
Applicant
Ferguson Medical
Chico, CA, US
Received
January 29, 1996
Decision date
April 16, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LWI – Ultrasound, Sinus
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1560
Specialty
Radiology

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Questions and answers

When was Sinuscan 102/SINUSPRINT cleared by the FDA?

Sinuscan 102/SINUSPRINT (K960421) received a 510(k) decision of Substantially Equivalent on April 16, 1997, 443 days after the submission was received.

What is the product code of K960421?

The FDA product code is LWI – Ultrasound, Sinus, a Class II (moderate risk) device regulated under 21 CFR 892.1560.