Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4)

Q: What is the product code of K994373?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.

FDA 510(k) K994373 · Atl Ultrasound, Inc.

Substantially Equivalent

510(k) numberK994373

Submission

Device name: Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4)
Applicant: Atl Ultrasound, Inc.
Bothell, WA, US
Received: December 27, 1999
Decision date: March 24, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ITX – Transducer, Ultrasonic, Diagnostic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1570
Specialty: Radiology

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Questions and answers

When was Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4) cleared by the FDA?

Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4) (K994373) received a 510(k) decision of Substantially Equivalent on March 24, 2000, 88 days after the submission was received.

What is the product code of K994373?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.