The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Natus Neuroworks, Model 104196.
| Device ID | K090019 |
| 510k Number | K090019 |
| Device Name: | NATUS NEUROWORKS, MODEL 104196 |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | NATUS MEDICAL, INC. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | Goldy Singh |
| Correspondent | Goldy Singh NATUS MEDICAL, INC. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Product Code | OMB |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-02 |
| Decision Date | 2010-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830042147 | K090019 | 000 |
| 00382830002745 | K090019 | 000 |
| 00382830019231 | K090019 | 000 |
| 00382830022224 | K090019 | 000 |
| 00382830022231 | K090019 | 000 |
| 00382830022248 | K090019 | 000 |
| 00382830022255 | K090019 | 000 |
| 00382830022262 | K090019 | 000 |
| 00382830022279 | K090019 | 000 |
| 00382830022286 | K090019 | 000 |
| 00382830022309 | K090019 | 000 |
| 00382830041898 | K090019 | 000 |
| 00382830041904 | K090019 | 000 |
| 00382830042123 | K090019 | 000 |
| 00382830002677 | K090019 | 000 |