Teratech, Model 2000 Imaging Imaging

Q: What is the product code of K992505?

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

FDA 510(k) K992505 · Teratech Corp.

Substantially Equivalent

510(k) numberK992505

Submission

Device name: Teratech, Model 2000 Imaging Imaging
Applicant: Teratech Corp.
North Attleboro, MA, US
Received: July 27, 1999
Decision date: November 10, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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 Teratech, Model 2000 Imaging Imaging cleared by the FDA?

Teratech, Model 2000 Imaging Imaging (K992505) received a 510(k) decision of Substantially Equivalent on November 10, 1999, 106 days after the submission was received.

What is the product code of K992505?

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