CO-OXIMETER SOLUTIONS
FDA 510(k) clearance K863825 · decided 1986-11-24
Clearance details
- K-number
- K863825
- Device name
- CO-OXIMETER SOLUTIONS
- Applicant
- D.R.G. Scientific Industries
- Decision
- Substantially Equivalent
- Date received
- 1986-09-30
- Decision date
- 1986-11-24
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- JKS
- Device class
- 1
- Regulation number
- 862.3220
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- East Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AVOXIMETER 4000 (K951485) | A-Vox Systems, Inc. | 1995-11-06 |
| 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
No recalls on record reference this clearance.