OSM3 Hemoximeter
FDA 510(k) K853990 · Radiometer America, Inc.
510(k) numberK853990
Submission
- Device name
- OSM3 Hemoximeter
- Applicant
- Radiometer America, Inc.
Westlake, OH, US - Received
- September 27, 1985
- Decision date
- December 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JKS – Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3220
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JKS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951485 | Avoximeter 4000JKS · Traditional | A-Vox Systems, Inc. | 11/06/1995SE |
| K863825 | Co-Oximeter SolutionsJKS · Traditional | D.R.G. Scientific Industries | 11/24/1986SE |
| K862253 | Il 482 Co-OximeterJKS · Traditional | Instrumentation Laboratory CO | 07/29/1986SE |
| K833693 | Tee Adapter 9890-FLUSH Winding 282JKS · Traditional | Shaban Mfg. Co. | 12/30/1983SE |
| K833211 | Bile Salts MixtureJKS · Traditional | Acumedia Manufacturers, Inc. | 10/27/1983SE |
| K832066 | Control 282JKS · Traditional | Bio-Nustics, Inc. | 09/29/1983SE |
| K780652 | Hemoglobin Check Solutions, S2100 OSM-2JKS · Traditional | The London Co. | 07/27/1978SE |
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Questions and answers
When was OSM3 Hemoximeter cleared by the FDA?
OSM3 Hemoximeter (K853990) received a 510(k) decision of Substantially Equivalent on December 30, 1985, 94 days after the submission was received.
What is the product code of K853990?
The FDA product code is JKS – Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide, a Class I (low risk) device regulated under 21 CFR 862.3220.