The following data is part of a premarket notification filed by Vgbio, Inc (dba Physiq) with the FDA for Personalized Physiology Analytics Engine Software.
| Device ID | K142512 |
| 510k Number | K142512 |
| Device Name: | Personalized Physiology Analytics Engine Software |
| Classification | Multivariate Vital Signs Index |
| Applicant | VGBio, Inc (DBA PhysIQ) 1415 West Diehl Road, Suite 150 Naperville, IL 60563 |
| Contact | Gary Conkright |
| Correspondent | Michael J Billig EXPERIEN GROUP, LLC 755 N MATHILDA AVENUE Suite 100 Sunnyvale, CA 94085 |
| Product Code | PLB |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-08 |
| Decision Date | 2015-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004366263 | K142512 | 000 |