The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Algo 3 Newborn Hearing Screener.
| Device ID | K013137 |
| 510k Number | K013137 |
| Device Name: | ALGO 3 NEWBORN HEARING SCREENER |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Sheila Ramerman |
| Correspondent | Sheila Ramerman NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-19 |
| Decision Date | 2001-10-16 |
| Summary: | summary |