510(k) K172159
K172159 is an FDA 510(k) premarket notification submitted by Maquet GmbH for the device "Getinge GSS67N Series Steam Sterilizer". The FDA issued a decision of Substantially Equivalent on January 30, 2018. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Maquet GmbH has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2018
- Date Received
- July 18, 2017
- 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