Ponto 3, Ponto 3 Power And Ponto 3 SuperPower

Hearing Aid, Bone Conduction

OTICON MEDICAL AB

The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Ponto 3, Ponto 3 Power And Ponto 3 Superpower.

Pre-market Notification Details

• Device ID: K161671
• 510k Number: K161671
• Device Name: Ponto 3, Ponto 3 Power And Ponto 3 SuperPower
• Classification: Hearing Aid, Bone Conduction
• Applicant: OTICON MEDICAL AB DATAVAGEN 37B Askim, SE Se-436 32
• Contact: Satu Hjartstam
• Correspondent: Satu Hjartstam; OTICON MEDICAL AB DATAVAGEN 37B Askim, SE Se-436 32
• Product Code: LXB
• Subsequent Product Code: ESD
• Subsequent Product Code: MAH
• CFR Regulation Number: 874.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-16
• Decision Date: 2016-09-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05712149011582	K161671	000
05712149011766	K161671	000
05712149011773	K161671	000
05712149011780	K161671	000
05712149011797	K161671	000
05712149011803	K161671	000
05712149011810	K161671	000
05712149011827	K161671	000
05712149011834	K161671	000
05712149011841	K161671	000
05712149011858	K161671	000
05712149011865	K161671	000
05712149011872	K161671	000
05712149011889	K161671	000
05712149011896	K161671	000
05712149011902	K161671	000
05712149011759	K161671	000
05712149011742	K161671	000
05712149011599	K161671	000
05712149011605	K161671	000
05712149011612	K161671	000
05712149011629	K161671	000
05712149011636	K161671	000
05712149011643	K161671	000
05712149011650	K161671	000
05712149011667	K161671	000
05712149011674	K161671	000
05712149011681	K161671	000
05712149011698	K161671	000
05712149011704	K161671	000
05712149011711	K161671	000
05712149011728	K161671	000
05712149011735	K161671	000
05712149011919	K161671	000
05712149011926	K161671	000
05712149014033	K161671	000
05712149014040	K161671	000
05712149024599	K161671	000
05712149024605	K161671	000
05712149024612	K161671	000
05712149024629	K161671	000
05712149024636	K161671	000
05712149024643	K161671	000
05712149024650	K161671	000
05712149024667	K161671	000
05712149024674	K161671	000
05712149024681	K161671	000
05712149024698	K161671	000
05712149024704	K161671	000
05712149024711	K161671	000
05712149014026	K161671	000
05712149014019	K161671	000
05712149011933	K161671	000
05712149011957	K161671	000
05712149011988	K161671	000
05712149011995	K161671	000
05712149013906	K161671	000
05712149013913	K161671	000
05712149013920	K161671	000
05712149013937	K161671	000
05712149013944	K161671	000
05712149013951	K161671	000
05712149013968	K161671	000
05712149013975	K161671	000
05712149013982	K161671	000
05712149013999	K161671	000
05712149014002	K161671	000
05712149024728	K161671	000