OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'— 510(k) K014218
Substantially EquivalentDolphin Medical, Inc.
FDA 510(k) clearance K014218 for OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210', Substantially Equivalent on 2002-11-07. Applicant: Dolphin Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Dolphin Medical, Inc.
- 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
- Tampa, FL, US
Recent devices under product code DQA
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K252655 — Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Dolphin Medical, Inc.
view all- K060524 — DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
- K040380 — DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
- K033876 — DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
- K032947 — NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210
- K031465 — MODEL 2100 PULSE OXIMETER
Adverse 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.