510(k) K211395
K211395 is an FDA 510(k) premarket notification submitted by Einstein Works, LLC for the device "NIO-I". The FDA issued a decision of Substantially Equivalent on Jul 28, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Einstein Works, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 2021
- Date Received
- May 5, 2021
- 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
- 510(k)