510(k) K855215
K855215 is an FDA 510(k) premarket notification submitted by Mira, Inc. for the device "AIR/FLUID EXCHANGE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 27, 1986. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Mira, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1986
- Date Received
- December 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type