The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Algo 3i Newborn Hearing Screener.
| Device ID | K030823 |
| 510k Number | K030823 |
| Device Name: | ALGO 3I NEWBORN HEARING SCREENER |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Ron Kohlhardt |
| Correspondent | Ron Kohlhardt 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 | 2003-03-14 |
| Decision Date | 2003-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830053679 | K030823 | 000 |
| 00382830044066 | K030823 | 000 |
| 00382830044059 | K030823 | 000 |
| 00382830044042 | K030823 | 000 |
| 00382830044035 | K030823 | 000 |
| 00382830044028 | K030823 | 000 |
| 00382830001526 | K030823 | 000 |
| 00382830001519 | K030823 | 000 |
| 00382830001489 | K030823 | 000 |
| 00382830000918 | K030823 | 000 |
| 00382830000901 | K030823 | 000 |
| 00382830000888 | K030823 | 000 |
| 00382830046183 | K030823 | 000 |
| 00382830047050 | K030823 | 000 |
| 00382830053662 | K030823 | 000 |
| 00382830053655 | K030823 | 000 |
| 00382830053648 | K030823 | 000 |
| 00382830053297 | K030823 | 000 |
| 00382830052177 | K030823 | 000 |
| 00382830052160 | K030823 | 000 |
| 00382830047104 | K030823 | 000 |
| 00382830047098 | K030823 | 000 |
| 00382830047081 | K030823 | 000 |
| 00382830047074 | K030823 | 000 |
| 00382830047067 | K030823 | 000 |
| 00382830000871 | K030823 | 000 |