510(k) K122071
K122071 is an FDA 510(k) premarket notification submitted by Getinge Sourcing, LLC for the device "GETINGE 400HC-E / SERIES STEAM STERILIZER". The FDA issued a decision of Substantially Equivalent on March 12, 2013. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Getinge Sourcing, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2013
- Date Received
- July 16, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Steam
- Device Class
- Class II
- Regulation Number
- 880.6880
- Review Panel
- HO
- Submission Type