MHLX7EC Transducer

FDA 510(k) K040213 · Microhelix, Inc.

Substantially Equivalent

510(k) numberK040213

Submission

Device name
MHLX7EC Transducer
Applicant
Microhelix, Inc.
Bainbridge Island, WA, US
Received
January 30, 2004
Decision date
September 22, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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 MHLX7EC Transducer cleared by the FDA?

MHLX7EC Transducer (K040213) received a 510(k) decision of Substantially Equivalent on September 22, 2004, 236 days after the submission was received.

What is the product code of K040213?

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