Bodygem, Model HB211
FDA 510(k) K010577 · Healthetech, Inc.
510(k) numberK010577
Submission
- Device name
- Bodygem, Model HB211
- Applicant
- Healthetech, Inc.
Los Gatos, CA, US - Received
- February 27, 2001
- Decision date
- January 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZL – Computer, Oxygen-Uptake
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1730
- Specialty
- Anesthesiology
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| K021490 | Reevue Indirect Calorimeter, MODEL#8100BZL · Traditional | Korr Medical Technologies, Inc. | 01/02/2003SE |
| K021605 | MedgemBZL · Special | Healthetech, Inc. | 06/14/2002SE |
| K954731 | Oxylog 2BZL · Traditional | P.K. Morgan , Ltd. | 01/06/1997SE |
More from P.K. Morgan , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K021605 | MedgemBZL · Special | 06/14/2002SE |
Questions and answers
When was Bodygem, Model HB211 cleared by the FDA?
Bodygem, Model HB211 (K010577) received a 510(k) decision of Substantially Equivalent on January 10, 2002, 317 days after the submission was received.
What is the product code of K010577?
The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.