510(k) K172095
K172095 is an FDA 510(k) premarket notification submitted by Medexel Co.,Ltd for the device "Autokeeper". The FDA issued a decision of Substantially Equivalent on July 24, 2018. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Medexel Co.,Ltd has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2018
- Date Received
- July 11, 2017
- 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