The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Algo-2 Newborn Hearing Screener.
| Device ID | K936039 |
| 510k Number | K936039 |
| Device Name: | ALGO-2 NEWBORN HEARING SCREENER |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Robert T Stone |
| Correspondent | Robert T Stone NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1995-01-05 |