510(k) K192556
K192556 is an FDA 510(k) premarket notification submitted by Bardy Diagnostics, Inc. for the device "Carnation Ambulatory Monitor". The FDA issued a decision of Substantially Equivalent on October 17, 2019. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Bardy Diagnostics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2019
- Date Received
- September 17, 2019
- Clearance Type
- Special
- 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