The following data is part of a premarket notification filed by Xerox Corp. with the FDA for 413a Neonatal Monitor.
| Device ID | K800164 |
| 510k Number | K800164 |
| Device Name: | 413A NEONATAL MONITOR |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | XEROX CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-25 |
| Decision Date | 1980-04-10 |