PEDIA PALS

Otoscope

PEDIA PALS, INC.

The following data is part of a premarket notification filed by Pedia Pals, Inc. with the FDA for Pedia Pals.

Pre-market Notification Details

• Device ID: K911650
• 510k Number: K911650
• Device Name: PEDIA PALS
• Classification: Otoscope
• Applicant: PEDIA PALS, INC. P.O. BOX 21934 1964 COLLINGWOOD ROAD Columbus, OH 43221
• Contact: Hansel, Jr.
• Correspondent: Hansel, Jr.; PEDIA PALS, INC. P.O. BOX 21934 1964 COLLINGWOOD ROAD Columbus, OH 43221
• Product Code: ERA
• CFR Regulation Number: 874.4770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-04-12
• Decision Date: 1991-10-17