510(k) K032723
K032723 is an FDA 510(k) premarket notification submitted by Getinge USA, Inc. for the device "BIOSIGN STEAM-24 BIOLOGICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on October 1, 2003. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Getinge USA, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2003
- Date Received
- September 3, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type