The following data is part of a premarket notification filed by Healthetech, Inc. with the FDA for Bodygem, Model Hb211.
| Device ID | K010577 |
| 510k Number | K010577 |
| Device Name: | BODYGEM, MODEL HB211 |
| Classification | Computer, Oxygen-uptake |
| Applicant | HEALTHETECH, INC. 325 LOS GATOS-SARATOGA RD. Los Gatos, CA 95070 |
| Contact | Noel L Johnson |
| Correspondent | Noel L Johnson HEALTHETECH, INC. 325 LOS GATOS-SARATOGA RD. Los Gatos, CA 95070 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-27 |
| Decision Date | 2002-01-10 |