510(k) K182344
K182344 is an FDA 510(k) premarket notification submitted by Biofourmis Singapore Pte., Ltd. for the device "RhythmAnalytics". The FDA issued a decision of Substantially Equivalent on March 7, 2019. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Biofourmis Singapore Pte., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 2019
- Date Received
- August 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type