TI500 GLOBE-TROTTER TRANSPORT SYSTEM
FDA 510(k) clearance K001019 · decided 2000-04-27
Clearance details
- K-number
- K001019
- Device name
- TI500 GLOBE-TROTTER TRANSPORT SYSTEM
- Applicant
- Hill-Rom Air-Shields
- Decision
- Substantially Equivalent
- Date received
- 2000-03-30
- Decision date
- 2000-04-27
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- FPL
- Device class
- 2
- Regulation number
- 880.5410
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hatboro, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical, In recall (Z-1052-2008) | Draeger Medical, Inc. | 2008-03-18 |
| Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 1896 recall (Z-1053-2008) | Draeger Medical, Inc. | 2008-03-18 |