PRISMA

Hearing Aid, Air Conduction

SIEMENS HEARING INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Prisma.

Pre-market Notification Details

• Device ID: K972998
• 510k Number: K972998
• Device Name: PRISMA
• Classification: Hearing Aid, Air Conduction
• Applicant: SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855
• Contact: Robert H Bea
• Correspondent: Robert H Bea; SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855
• Product Code: ESD
• CFR Regulation Number: 874.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-08-12
• Decision Date: 1997-09-05
• Summary: summary