Britt Lens Computer

FDA 510(k) K790694 · Britt Corp., Inc.

Substantially Equivalent

510(k) numberK790694

Submission

Device name
Britt Lens Computer
Applicant
Britt Corp., Inc.
Mchenry, IL, US
Received
April 10, 1979
Decision date
August 10, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1560
Specialty
Radiology

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Questions and answers

When was Britt Lens Computer cleared by the FDA?

Britt Lens Computer (K790694) received a 510(k) decision of Substantially Equivalent on August 10, 1979, 122 days after the submission was received.

What is the product code of K790694?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.