510(k) K001019
K001019 is an FDA 510(k) premarket notification submitted by Hill-Rom Air-Shields for the device "TI500 GLOBE-TROTTER TRANSPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 27, 2000. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Hill-Rom Air-Shields has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2000
- Date Received
- March 30, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal Transport
- Device Class
- Class II
- Regulation Number
- 880.5410
- Review Panel
- HO
- Submission Type