The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Siemens Pc Auidiometer Model Sd 100 & Pc Probe Mic System Model Sd 110/sd With Unity Sopftware Suite.
| Device ID | K952098 |
| 510k Number | K952098 |
| Device Name: | SIEMENS PC AUIDIOMETER MODEL SD 100 & PC PROBE MIC SYSTEM MODEL SD 110/SD WITH UNITY SOPFTWARE SUITE |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| 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 | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-04 |
| Decision Date | 1995-05-25 |