THE STERN ERA SYSTEM

Otoscope

STERNGOLD/IMPLAMED

The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for The Stern Era System.

Pre-market Notification Details

• Device ID: K913348
• 510k Number: K913348
• Device Name: THE STERN ERA SYSTEM
• Classification: Otoscope
• Applicant: STERNGOLD/IMPLAMED C/O MEDICAL DEVICE CONULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703
• Contact: Frank S Casciani
• Correspondent: Frank S Casciani; STERNGOLD/IMPLAMED C/O MEDICAL DEVICE CONULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703
• Product Code: ERA
• CFR Regulation Number: 874.4770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-07-26
• Decision Date: 1992-01-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841549101144	K913348	000
00841549101007	K913348	000
00841549100994	K913348	000
00841549100628	K913348	000
00841549102165	K913348	000
00841549102158	K913348	000
00841549102141	K913348	000
00841549102134	K913348	000
00841549102127	K913348	000
00841549101014	K913348	000
00841549101038	K913348	000
00841549101052	K913348	000
00841549101137	K913348	000
00841549101120	K913348	000
00841549101113	K913348	000
00841549101106	K913348	000
00841549101090	K913348	000
00841549101083	K913348	000
00841549101076	K913348	000
00841549101069	K913348	000
00841549102110	K913348	000
00841549102103	K913348	000
00841549102028	K913348	000
00841549101908	K913348	000
00841549101892	K913348	000
00841549101885	K913348	000
00841549101878	K913348	000
00841549101274	K913348	000
00841549100987	K913348	000
00841549101625	K913348	000
00841549115745	K913348	000
00841549101915	K913348	000
00841549101922	K913348	000
00841549101939	K913348	000
00841549102011	K913348	000
00841549102004	K913348	000
00841549101991	K913348	000
00841549101984	K913348	000
00841549101977	K913348	000
00841549101960	K913348	000
00841549101953	K913348	000
00841549101946	K913348	000
00841549115738	K913348	000
08415491134400	K913348	000
08415491044181	K913348	000
08415491044174	K913348	000
08415491044167	K913348	000
08415491044150	K913348	000
08415491044143	K913348	000
08415491044136	K913348	000
08415491044129	K913348	000
08415491044112	K913348	000
08415491044532	K913348	000
08415491044549	K913348	000
08415491052582	K913348	000
08415491134394	K913348	000
08415491134387	K913348	000
08415491134370	K913348	000
08415491134363	K913348	000
08415491134356	K913348	000
08415491134295	K913348	000
08415491134288	K913348	000
08415491124722	K913348	000
08415491043825	K913348	000
08415491043818	K913348	000
08415491043801	K913348	000
00841549101632	K913348	000
00841549101618	K913348	000
00841549101595	K913348	000
00841549101205	K913348	000
00841549101199	K913348	000
00841549101182	K913348	000
00841549101175	K913348	000
00841549101168	K913348	000
00841549101649	K913348	000
00841549101656	K913348	000
00841549101663	K913348	000
08415491043795	K913348	000
08415491043788	K913348	000
00841549101724	K913348	000
00841549101717	K913348	000
00841549101700	K913348	000
00841549101694	K913348	000
00841549101687	K913348	000
00841549101670	K913348	000
00841549101151	K913348	000