510(k) K954204
K954204 is an FDA 510(k) premarket notification submitted by Drager, Inc. for the device "DRAGER INCUBATOR 8000 IC". The FDA issued a decision of Substantially Equivalent on April 25, 1997. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Drager, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1997
- Date Received
- September 6, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal
- Device Class
- Class II
- Regulation Number
- 880.5400
- Review Panel
- HO
- Submission Type