The following data is part of a premarket notification filed by Hill-rom Air-shields with the FDA for Ti500 Globe-trotter Transport System.
| Device ID | K001019 |
| 510k Number | K001019 |
| Device Name: | TI500 GLOBE-TROTTER TRANSPORT SYSTEM |
| Classification | Incubator, Neonatal Transport |
| Applicant | HILL-ROM AIR-SHIELDS 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Contact | James G Carpenter |
| Correspondent | James G Carpenter HILL-ROM AIR-SHIELDS 330 JACKSONVILLE RD. Hatboro, PA 19040 |
| Product Code | FPL |
| CFR Regulation Number | 880.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-30 |
| Decision Date | 2000-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098000192 | K001019 | 000 |