The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for 515a Neo-trak Neonatal Monitor.
| Device ID | K861861 |
| 510k Number | K861861 |
| Device Name: | 515A NEO-TRAK NEONATAL MONITOR |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Joseph P Lenzen |
| Correspondent | Joseph P Lenzen GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-14 |
| Decision Date | 1986-07-10 |