Question 1

Who is the manufacturer of VARIABLE FOCUS 3.5 MHZ TRANSDUCER?

Accepted Answer

Adr Ultrasound filed the 510(k) submission for VARIABLE FOCUS 3.5 MHZ TRANSDUCER (K812301).

Question 2

What is the FDA product code for VARIABLE FOCUS 3.5 MHZ TRANSDUCER?

Accepted Answer

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

Question 3

When was VARIABLE FOCUS 3.5 MHZ TRANSDUCER cleared by the FDA?

Accepted Answer

Nov 16, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for VARIABLE FOCUS 3.5 MHZ TRANSDUCER?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like VARIABLE FOCUS 3.5 MHZ TRANSDUCER?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K812301
Device Name	VARIABLE FOCUS 3.5 MHZ TRANSDUCER
Applicant	Adr Ultrasound
Product Code	ITX · Radiology
Decision Date	Nov 16, 1981
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1570
Device Class	Class 2

VARIABLE FOCUS 3.5 MHZ TRANSDUCER

Device Facts

Regulatory Classification

Identification