TI500 Globe-Trotter Transport System
FDA 510(k) K001019 · Hill-Rom Air-Shields
510(k) numberK001019
Submission
- Device name
- TI500 Globe-Trotter Transport System
- Applicant
- Hill-Rom Air-Shields
Hatboro, PA, US - Received
- March 30, 2000
- Decision date
- April 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPL – Incubator, Neonatal Transport
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5410
- Specialty
- General Hospital
Other 510(k)s with product code FPL
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|---|---|---|---|
| K220742 | NxtGen Infant Transport IncubatorFPL · Traditional | International Biomedical | 07/15/2022SE |
| K161918 | SREE MRI Transport IncubatorFPL · Traditional | Advanced Imaging Research Dba Sree Medical Systems | 03/03/2017SE |
| K141565 | Globe-Trotter GT5400FPL · Traditional | Draeger Medical Systems, Inc. | 09/10/2014SE |
| K123937 | Atom Transcapsule V-707FPL · Traditional | Atom Medical Corporation | 05/23/2013SE |
| K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…FPL · Special | International Biomedical, Ltd. | 05/11/2011SE |
| K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…FPL · Special | International Biomedical, Ltd. | 05/11/2011SE |
| K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with…FPL · Special | International Biomedical, Ltd. | 04/15/2011SE |
| K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with…FPL · Special | International Biomedical, Ltd. | 04/15/2011SE |
| K081399 | Aviator Transport IncubatorFPL · Special | International Biomedical, Ltd. | 06/06/2008SE |
| K061071 | V-808 Atom TranscapsuleFPL · Traditional | Atom Medical, Inc. | 08/29/2006SE |
More from Atom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103MQM · Traditional | 04/01/2003SE |
| K003335 | Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted…FMT · Special | 11/17/2000SE |
| K001242 | Isolette Infant Incubator, Model C2HSFMZ · Traditional | 07/13/2000SE |
| K993051 | Versalet 7700 Care Center, Model # 7700FMZ · Traditional | 02/03/2000SE |
Questions and answers
When was TI500 Globe-Trotter Transport System cleared by the FDA?
TI500 Globe-Trotter Transport System (K001019) received a 510(k) decision of Substantially Equivalent on April 27, 2000, 28 days after the submission was received.
What is the product code of K001019?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.