510(k) K190493
K190493 is an FDA 510(k) premarket notification submitted by Mego Afek AC , Ltd. for the device "Recovery Pump, 737R (RPX)". The FDA issued a decision of Substantially Equivalent on May 15, 2019. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Mego Afek AC , Ltd. has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2019
- Date Received
- Feb 28, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type
- 510(k)