510(k) K022248
K022248 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "STRYKER L3 HYDROLERT". The FDA issued a decision of Substantially Equivalent on Aug 6, 2002. The device falls under product code FLN (Monitor, Electric For Gravity Flow Infusion Systems), a Class II device regulated under 21 CFR 880.2420. Stryker Endoscopy has 102 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 6, 2002
- Date Received
- Jul 12, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Monitor, Electric For Gravity Flow Infusion Systems
- Device Class
- Class II
- Regulation Number
- 880.2420
- Review Panel
- HO
- Submission Type
- 510(k)