AVOXIMETER
FDA 510(k) clearance K922075 · decided 1992-11-04
Clearance details
- K-number
- K922075
- Device name
- AVOXIMETER
- Applicant
- A-Vox Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-04
- Decision date
- 1992-11-04
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated be recall (Z-0279-2025) | Accriva Diagnostics, Inc. | 2024-10-31 |
| International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-1 recall (Z-1237-2008) | International Technidyne Corp. | 2008-08-06 |
| International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E recall (Z-1238-2008) | International Technidyne Corp. | 2008-08-06 |