The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Infinity 252.
| Device ID | K935019 |
| 510k Number | K935019 |
| Device Name: | INFINITY 252 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. Piscataway, NJ 08855 |
| Contact | Gary W Roesel |
| Correspondent | Gary W Roesel SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. 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 | 1993-10-20 |
| Decision Date | 1994-09-07 |