TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES

Audiometer

ETYMOTIC RESEARCH

The following data is part of a premarket notification filed by Etymotic Research with the FDA for Tubephone Models Er-3a & Er-3 Insert Earphones.

Pre-market Notification Details

• Device ID: K930003
• 510k Number: K930003
• Device Name: TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
• Classification: Audiometer
• Applicant: ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007
• Contact: Edwin L Devilbiss
• Correspondent: Edwin L Devilbiss; ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-01-04
• Decision Date: 1993-06-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00846430005426	K930003	000
00846430004429	K930003	000
00846430004436	K930003	000
00846430004443	K930003	000
00846430004450	K930003	000
00846430004467	K930003	000
00846430004481	K930003	000
00846430004498	K930003	000
00846430004504	K930003	000
00846430004511	K930003	000
00846430004528	K930003	000
00846430004412	K930003	000
00846430004405	K930003	000
00846430004139	K930003	000
00846430005457	K930003	000
00846430005464	K930003	000
00846430005471	K930003	000
00846430005495	K930003	000
00846430005563	K930003	000
00846430005440	K930003	000
00846430005488	K930003	000
00846430005334	K930003	000
00846430005402	K930003	000
00846430005419	K930003	000
00846430004535	K930003	000
00846430004542	K930003	000
00846430004788	K930003	000
00846430004795	K930003	000
00846430004986	K930003	000
00846430004993	K930003	000
00846430005044	K930003	000
00846430005051	K930003	000
00846430005075	K930003	000
00846430005198	K930003	000
00846430005204	K930003	000
00846430005280	K930003	000
00846430004771	K930003	000
00846430004764	K930003	000
00846430004757	K930003	000
00846430004559	K930003	000
00846430004566	K930003	000
00846430004573	K930003	000
00846430004634	K930003	000
00846430004641	K930003	000
00846430004658	K930003	000
00846430004665	K930003	000
00846430004672	K930003	000
00846430004733	K930003	000
00846430004740	K930003	000
00846430005310	K930003	000