Question 1

Who is the manufacturer of GSI AUDERA?

Accepted Answer

Nicolet Biomedical filed the 510(k) submission for GSI AUDERA (K011135).

Question 2

What is the FDA product code for GSI AUDERA?

Accepted Answer

EWO. It is classified under 21 CFR 874.1050 as a Class 2 device in the Ear, Nose, Throat panel.

Question 3

When was GSI AUDERA cleared by the FDA?

Accepted Answer

Jul 26, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for GSI AUDERA?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like GSI AUDERA?

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	K011135
Device Name	GSI AUDERA
Applicant	Nicolet Biomedical
Product Code	EWO · Ear, Nose, Throat
Decision Date	Jul 26, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1050
Device Class	Class 2

GSI AUDERA

Device Facts

Regulatory Classification

Identification