The following data is part of a premarket notification filed by Stayhealthy, Inc. with the FDA for Stayhealthy Body Composition Monitor-bcm.
| Device ID | K101807 |
| 510k Number | K101807 |
| Device Name: | STAYHEALTHY BODY COMPOSITION MONITOR-BCM |
| Classification | Analyzer, Body Composition |
| Applicant | STAYHEALTHY, INC. 724 E. HUNTINGTON DRIVE Monrovia, CA 91016 |
| Contact | Jesus Farinas |
| Correspondent | Jesus Farinas STAYHEALTHY, INC. 724 E. HUNTINGTON DRIVE Monrovia, CA 91016 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-28 |
| Decision Date | 2011-01-26 |