510(k) K203638
K203638 is an FDA 510(k) premarket notification submitted by Atsens Co., Ltd. for the device "AT-Patch ECG Analysis System". The FDA issued a decision of Substantially Equivalent on October 12, 2022. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Atsens Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2022
- Date Received
- December 14, 2020
- 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