The following data is part of a premarket notification filed by Stayhealthy, Inc. with the FDA for Stayhealthy Health Kiosk, Stayhealthy Healthcenter Kiosk.
| Device ID | K123539 |
| 510k Number | K123539 |
| Device Name: | STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | STAYHEALTHY, INC. 24 EAST HUNGTINGTON DRIVE Monrovia, CA 91016 |
| Contact | Colin Hill Phd. |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXN |
| Subsequent Product Code | HIT |
| Subsequent Product Code | MNW |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-11-16 |
| Decision Date | 2013-04-22 |