510(k) K193662
K193662 is an FDA 510(k) premarket notification submitted by Eezcare Medical Corp for the device "Ezlymph, Ezlymph M". The FDA issued a decision of Substantially Equivalent on Feb 11, 2021. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Eezcare Medical Corp has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 2021
- Date Received
- Dec 31, 2019
- Clearance Type
- Abbreviated
- 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)