Question 1

Who is the manufacturer of UNI III?

Accepted Answer

Rudolf Riester GmbH & Co. KG filed the 510(k) submission for UNI III (K925753).

Question 2

What is the FDA product code for UNI III?

Accepted Answer

ERA. It is classified under 21 CFR 874.4770 as a Class 1 device in the Ear, Nose, Throat panel.

Question 3

When was UNI III cleared by the FDA?

Accepted Answer

Oct 8, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for UNI III?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like UNI III?

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	K925753
Device Name	UNI III
Applicant	Rudolf Riester GmbH & Co. KG
Product Code	ERA · Ear, Nose, Throat
Decision Date	Oct 8, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4770
Device Class	Class 1

UNI III

Device Facts

Regulatory Classification

Identification