510(k) K974253
K974253 is an FDA 510(k) premarket notification submitted by Scieran Technologies, Inc. for the device "CPD COMMANDER". The FDA issued a decision of Substantially Equivalent on February 25, 1998. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. Scieran Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1998
- Date Received
- November 13, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- OP
- Submission Type