The following data is part of a premarket notification filed by Natus Medical Incorporated Dba Excel-tech Ltd. (xltek) with the FDA for Background Pattern Classification [bpc(tm)].
| Device ID | K152301 |
| 510k Number | K152301 |
| Device Name: | Background Pattern Classification [BPc(TM)] |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) 2568 Bristol Circle Oakville, CA L6h5s1 |
| Contact | Sanjay Mehta |
| Correspondent | Sanjay Mehta Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) 2568 Bristol Circle Oakville, CA L6h5s1 |
| Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-14 |
| Decision Date | 2016-06-03 |
| Summary: | summary |