The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Unity 2 Hia & Probe ( For Use With Unity 2).
| Device ID | K071462 |
| 510k Number | K071462 |
| Device Name: | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) |
| Classification | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CONSTITUTION AVE. P.O. BOX 1397 Piscataway, NJ 08855 |
| Contact | Jon Schirado |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ETW |
| CFR Regulation Number | 874.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-25 |
| Decision Date | 2007-06-05 |
| Summary: | summary |