510(k) K010577
K010577 is an FDA 510(k) premarket notification submitted by Healthetech, Inc. for the device "BODYGEM, MODEL HB211". The FDA issued a decision of Substantially Equivalent on January 10, 2002. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Healthetech, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2002
- Date Received
- February 27, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Oxygen-Uptake
- Device Class
- Class II
- Regulation Number
- 868.1730
- Review Panel
- AN
- Submission Type