510(k) K161613
K161613 is an FDA 510(k) premarket notification submitted by Rand S.R.L. for the device "Hang&Go PAC". The FDA issued a decision of Substantially Equivalent on December 28, 2016. The device falls under product code LGZ (Warmer, Thermal, Infusion Fluid), a Class II device regulated under 21 CFR 880.5725. Rand S.R.L. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 2016
- Date Received
- June 10, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Thermal, Infusion Fluid
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type