510(k) K171410
K171410 is an FDA 510(k) premarket notification submitted by Braemar Manufacturing, LLC for the device "ePatch". The FDA issued a decision of Substantially Equivalent on January 4, 2018. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Braemar Manufacturing, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2018
- Date Received
- May 15, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type