510(k) K240915
K240915 is an FDA 510(k) premarket notification submitted by Zien Medical Technologies, Inc. for the device "ZIEN IO Intraosseous Access System". The FDA issued a decision of Substantially Equivalent on July 2, 2024. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Zien Medical Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2024
- Date Received
- April 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type