510(k) K213553
K213553 is an FDA 510(k) premarket notification submitted by Datex Ohmeda, Inc. for the device "Giraffe Incubator Carestation CS1". The FDA issued a decision of Substantially Equivalent on March 2, 2022. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Datex Ohmeda, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2022
- Date Received
- November 8, 2021
- 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