MODEL 3500 MR-COMPATIBLE PULSE OXIMETER— 510(k) K924285
Substantially EquivalentMagnetic Resonance Equipment Corp.
FDA 510(k) clearance K924285 for MODEL 3500 MR-COMPATIBLE PULSE OXIMETER, Substantially Equivalent on 1993-05-11. Applicant: Magnetic Resonance Equipment Corp.. Device class: 2.
Clearance details
- Applicant
- Magnetic Resonance Equipment Corp.
- Product code
- Code DQA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bay Shore, NY, US
Recent devices under product code DQA
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- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Magnetic Resonance Equipment Corp.
view allAdverse events under product code DQA
product code DQA- Death
- 66
- Malfunction
- 2,867
- Other
- 1
- Total
- 2,934
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.