510(k) K173541
K173541 is an FDA 510(k) premarket notification submitted by Imedicom Co., Ltd. for the device "EPINAUT". The FDA issued a decision of Substantially Equivalent on August 24, 2018. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Imedicom Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2018
- Date Received
- November 15, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Conduction, Anesthetic
- Device Class
- Class II
- Regulation Number
- 868.5120
- Review Panel
- AN
- Submission Type