The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Siemens Frontier Serice, Models S-1,s-2 And S-3 Multiple Situation, Single Channel Programmable Instruments.
| Device ID | K944645 |
| 510k Number | K944645 |
| Device Name: | SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS |
| Classification | Hearing Aid, Air Conduction |
| Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855 |
| Contact | Gary W Roesel |
| Correspondent | Gary W Roesel 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 | 1994-09-21 |
| Decision Date | 1994-12-27 |