510(k) K190976
K190976 is an FDA 510(k) premarket notification submitted by Radial Medical, Inc. for the device "Radial Medical Compression System". The FDA issued a decision of Substantially Equivalent on Jul 12, 2019. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Radial Medical, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 12, 2019
- Date Received
- Apr 15, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type
- 510(k)