Product code JKS
- Device name
- Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- Medical specialty
- Clinical Toxicology
- Device class
- 1
- Regulation number
- 862.3220
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951485 | AVOXIMETER 4000 | A-Vox Systems, Inc. | 1995-11-06 |
| K863825 | CO-OXIMETER SOLUTIONS | D.R.G. Scientific Industries | 1986-11-24 |
| K862253 | IL 482 CO-OXIMETER | Instrumentation Laboratory CO | 1986-07-29 |
| K853990 | OSM3 HEMOXIMETER | Radiometer America, Inc. | 1985-12-30 |
| K833693 | TEE ADAPTER 9890-FLUSH WINDING 282 | Shaban Mfg. Co. | 1983-12-30 |
| K833211 | BILE SALTS MIXTURE | Acumedia Manufacturers, Inc. | 1983-10-27 |
| K832066 | CONTROL 282 | Bio-Nustics, Inc. | 1983-09-29 |
| K780652 | HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 | The London Co. | 1978-07-27 |
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| 00385480362597 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
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