The following data is part of a premarket notification filed by Narco Scientific with the FDA for Ti-1000 Transport Incubator.
| Device ID | K831028 |
| 510k Number | K831028 |
| Device Name: | TI-1000 TRANSPORT INCUBATOR |
| Classification | Incubator, Neonatal Transport |
| Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-30 |
| Decision Date | 1983-05-09 |