510(k) K181363
K181363 is an FDA 510(k) premarket notification submitted by H R Pharmaceuticals, Inc. for the device "EcoVue Sterile and Non-Sterile Ultrasound Gels". The FDA issued a decision of Substantially Equivalent on June 13, 2018. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. H R Pharmaceuticals, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2018
- Date Received
- May 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Media, Coupling, Ultrasound
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type