510(k) K122787
K122787 is an FDA 510(k) premarket notification submitted by Simple Diagnostics, Inc. for the device "COMFORT EZ". The FDA issued a decision of Substantially Equivalent on December 6, 2012. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Simple Diagnostics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2012
- Date Received
- September 11, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type