AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM— 510(k) K093260
Substantially EquivalentInternational Biomedical, Ltd.
FDA 510(k) clearance K093260 for AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM, Substantially Equivalent on 2009-12-16. Applicant: International Biomedical, Ltd.. Device class: 2.
Clearance details
- Applicant
- International Biomedical, Ltd.
- Product code
- Code MRN
- Device class
- Class 2
- Regulation
- 21 CFR 868.5165
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Recent devices under product code MRN
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- K103524 — VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K103527 — AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
- K081399 — AVIATOR TRANSPORT INCUBATOR
Adverse events under product code MRN
product code MRN- Death
- 9
- Malfunction
- 910
- Total
- 919
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.