Pedia Pals

FDA 510(k) K911650 · Pedia Pals, Inc.

Substantially Equivalent

510(k) numberK911650

Submission

Device name
Pedia Pals
Applicant
Pedia Pals, Inc.
Columbus, OH, US
Received
April 12, 1991
Decision date
October 17, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

510(k)DeviceApplicantDecision
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
K950788Otoscope A-34ERA · Traditional Neitz Instruments Company, Ltd.05/03/1995SE
K951050Speculum, ENT (S3)ERA · Traditional Pedia Pals, Inc.04/17/1995SE
K951049Speculum, ENT (S3)ERA · Traditional Pedia Pals, Inc.04/17/1995SE

More from Pedia Pals, Inc.

510(k)DeviceDecision
K951041Blood Pressure Cuff 3DXQ · Traditional 10/31/1995SE
K951040Blood Pressure Cuff 2DXQ · Traditional 10/31/1995SE
K951039Blood Pressure Cuff 1DXQ · Traditional 10/31/1995SE
K951050Speculum, ENT (S3)ERA · Traditional 04/17/1995SE
K951049Speculum, ENT (S3)ERA · Traditional 04/17/1995SE
K950086Pedia Pals, IncorporatedEPY · Traditional 02/07/1995SE

Questions and answers

When was Pedia Pals cleared by the FDA?

Pedia Pals (K911650) received a 510(k) decision of Substantially Equivalent on October 17, 1991, 188 days after the submission was received.

What is the product code of K911650?

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