The following data is part of a premarket notification filed by Biofourmis Singapore Pte. Ltd with the FDA for Biovitals Analytics Engine.
| Device ID | K183282 |
| 510k Number | K183282 |
| Device Name: | Biovitals Analytics Engine |
| Classification | Multivariate Vital Signs Index |
| Applicant | Biofourmis Singapore Pte. Ltd Vision Exchange, #07-15, 2 Venture Drive Singapore, SG 608526 |
| Contact | Kuldeep Singh Rajput |
| Correspondent | Rakesh Lal Rakesh Lal 7 Courtyard Pl Lexington, MA 02420 |
| Product Code | PLB |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-26 |
| Decision Date | 2019-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08885018690021 | K183282 | 000 |