Otoscope A-34

FDA 510(k) K950788 · Neitz Instruments Company, Ltd.

Substantially Equivalent

510(k) numberK950788

Submission

Device name
Otoscope A-34
Applicant
Neitz Instruments Company, Ltd.
Tokyo, JP
Received
February 21, 1995
Decision date
May 3, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ERA – Otoscope
Device class
Class I (low risk)
Regulation
21 CFR 874.4770
Specialty
Ear, Nose, Throat

Other 510(k)s with product code ERA

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K123821Aio HD OtoscopeERA · Traditional Blue Focus05/17/2013SE
K121326Lantos 3D Ear ScannerERA · Traditional Lantos Technologies01/25/2013SE
K110326Osram ItosERA · Traditional Osram Sylvania, Inc.10/27/2011SE
K945264Optus OtoscopesERA · Traditional Optus, Inc.02/02/1996SE
K955043Welch Allyn Bi-OtoscopeERA · Traditional Welch Allyn, Inc.11/14/1995SE
K952578Welch Ally OtoscopeERA · Traditional Welch Allyn, Inc.07/10/1995SE
K950913Perfect, ENT Set, Praktikant, de LuxeERA · Traditional Rudolf Riester GmbH & Co. KG05/12/1995SE
K951050Speculum, ENT (S3)ERA · Traditional Pedia Pals, Inc.04/17/1995SE
K951049Speculum, ENT (S3)ERA · Traditional Pedia Pals, Inc.04/17/1995SE
K951255Imedge Video Ostoscope (Analog)ERA · Traditional Introspect, Inc.04/13/1995SE

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Questions and answers

When was Otoscope A-34 cleared by the FDA?

Otoscope A-34 (K950788) received a 510(k) decision of Substantially Equivalent on May 3, 1995, 71 days after the submission was received.

What is the product code of K950788?

The FDA product code is ERA – Otoscope, a Class I (low risk) device regulated under 21 CFR 874.4770.