Anascient Breath Monitor
FDA 510(k) K110810 · Invoy Technologies, LLC
510(k) numberK110810
Submission
- Device name
- Anascient Breath Monitor
- Applicant
- Invoy Technologies, LLC
Chandler, AZ, US - Received
- March 23, 2011
- Decision date
- June 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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 |
| K010577 | Bodygem, Model HB211BZL · Traditional | Healthetech, Inc. | 01/10/2002SE |
| K954731 | Oxylog 2BZL · Traditional | P.K. Morgan , Ltd. | 01/06/1997SE |
Questions and answers
When was Anascient Breath Monitor cleared by the FDA?
Anascient Breath Monitor (K110810) received a 510(k) decision of Substantially Equivalent on June 21, 2011, 90 days after the submission was received.
What is the product code of K110810?
The FDA product code is BZL – Computer, Oxygen-Uptake, a Class II (moderate risk) device regulated under 21 CFR 868.1730.