OPTICATH— 510(k) K820674
Substantially EquivalentOximetrix, Inc.
FDA 510(k) clearance K820674 for OPTICATH, Substantially Equivalent on 1982-03-25. Applicant: Oximetrix, Inc.. Device class: 2.
Clearance details
- Applicant
- Oximetrix, Inc.
- Product code
- Code DQE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1230
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DQE
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- K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
- K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
More clearances from Oximetrix, Inc.
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