510(k) K983947
K983947 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "AMERSE 2". The FDA issued a decision of Substantially Equivalent on December 4, 1998. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. STERIS Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1998
- Date Received
- November 5, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disinfectant, Medical Devices
- Device Class
- Class I
- Regulation Number
- 880.6890
- Review Panel
- HO
- Submission Type