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 |