The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Siemens Model 604 Pp, Behind-the-ear Hearing Aid.
| Device ID | K911810 |
| 510k Number | K911810 |
| Device Name: | SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855 |
| Contact | Pamela L Branderbit |
| Correspondent | Pamela L Branderbit 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 | 1991-04-23 |
| Decision Date | 1991-06-26 |