The following data is part of a premarket notification filed by Biointellisense Inc. with the FDA for Biosticker System.
| Device ID | K191614 |
| 510k Number | K191614 |
| Device Name: | BioSticker System |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | BioIntelliSense Inc. 570 El Camino Real, Suite 200 Redwood City, CA 94063 |
| Contact | Henry Leung |
| Correspondent | Henry Leung BioIntelliSense Inc. 570 El Camino Real, Suite 200 Redwood City, CA 94063 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005949046 | K191614 | 000 |
| 00850005949008 | K191614 | 000 |
| 10850005949104 | K191614 | 000 |
| 10850005949142 | K191614 | 000 |
| 10850005949180 | K191614 | 000 |
| 00850005949299 | K191614 | 000 |
| 10850005949227 | K191614 | 000 |