510(k) K260326
K260326 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)". The FDA issued a decision of Substantially Equivalent on Jul 28, 2026. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Datex-Ohmeda, Inc. has 98 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 2026
- Date Received
- Jan 30, 2026
- 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
- 510(k)