510(k) K912471
K912471 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "EAGLE 3000 SDS". The FDA issued a decision of Substantially Equivalent on June 26, 1992. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Amsco Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 1992
- Date Received
- June 4, 1991
- 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