Round Window Cath

FDA 510(k) K965115 · Neuro-Biometrix, Inc.

Substantially Equivalent

510(k) numberK965115

Submission

Device name
Round Window Cath
Applicant
Neuro-Biometrix, Inc.
Denver, CO, US
Received
December 20, 1996
Decision date
March 10, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ETD – Tube, Tympanostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3880
Specialty
Ear, Nose, Throat
Implant
Yes

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More from Medtronic Xomed, Inc.

510(k)DeviceDecision
K973740Round Window E-CathETD · Traditional 03/23/1998SE

Questions and answers

When was Round Window Cath cleared by the FDA?

Round Window Cath (K965115) received a 510(k) decision of Substantially Equivalent on March 10, 1997, 80 days after the submission was received.

What is the product code of K965115?

The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.