The following data is part of a premarket notification filed by Stayhealthy, Inc. with the FDA for Stayhealthy Body Composition Analyzer, Models Bc1 And Bc2.
| Device ID | K052522 |
| 510k Number | K052522 |
| Device Name: | STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 |
| Classification | Analyzer, Body Composition |
| Applicant | STAYHEALTHY, INC. 300 ELFWOOD DRIVE Monrovia, CA 91016 |
| Contact | Colin K Hill |
| Correspondent | Colin K Hill STAYHEALTHY, INC. 300 ELFWOOD 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 | 2005-09-14 |
| Decision Date | 2005-12-13 |
| Summary: | summary |