510(k) K141565
K141565 is an FDA 510(k) premarket notification submitted by Draeger Medical Systems, Inc. for the device "GLOBE-TROTTER GT5400". The FDA issued a decision of Substantially Equivalent on September 10, 2014. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Draeger Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2014
- Date Received
- June 12, 2014
- 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