AVOXIMETER 4000
FDA 510(k) clearance K951485 · decided 1995-11-06
Clearance details
- K-number
- K951485
- Device name
- AVOXIMETER 4000
- Applicant
- A-Vox Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-30
- Decision date
- 1995-11-06
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- JKS
- Device class
- 1
- Regulation number
- 862.3220
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch A-Vox Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CO-OXIMETER SOLUTIONS (K863825) | D.R.G. Scientific Industries | 1986-11-24 |
| IL 482 CO-OXIMETER (K862253) | Instrumentation Laboratory CO | 1986-07-29 |
| OSM3 HEMOXIMETER (K853990) | Radiometer America, Inc. | 1985-12-30 |
| TEE ADAPTER 9890-FLUSH WINDING 282 (K833693) | Shaban Mfg. Co. | 1983-12-30 |
| BILE SALTS MIXTURE (K833211) | Acumedia Manufacturers, Inc. | 1983-10-27 |
| CONTROL 282 (K832066) | Bio-Nustics, Inc. | 1983-09-29 |
| HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (K780652) | The London Co. | 1978-07-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AVOXimeter 1000, AVOXimeter 4000 1000- portable bedside whole blood oximeter that directly recall (Z-2218-2011) | International Technidyne Corp. | 2011-05-19 |
| International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX400 recall (Z-1239-2008) | International Technidyne Corp. | 2008-08-06 |