510(k) K033565
K033565 is an FDA 510(k) premarket notification submitted by Lmt Lammers Medical Technology GmbH for the device "LMT NOMAG IC 1,5". The FDA issued a decision of Substantially Equivalent on November 21, 2003. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Lmt Lammers Medical Technology GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2003
- Date Received
- November 12, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Incubator, Neonatal Transport
- Device Class
- Class II
- Regulation Number
- 880.5410
- Review Panel
- HO
- Submission Type