The following data is part of a premarket notification filed by Biofourmis Singapore Pte. Ltd. with the FDA for Rhythmanalytics.
| Device ID | K182344 |
| 510k Number | K182344 |
| Device Name: | RhythmAnalytics |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Biofourmis Singapore Pte. Ltd. Vision Exchange, #07-15, 2 Venture Drive Singapore, SG 608526 |
| Contact | Kuldeep Singh Rajput |
| Correspondent | Michael Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2019-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08885018690014 | K182344 | 000 |