REFLECTANCE SENSOR (RS-10)— 510(k) K904039
Substantially EquivalentNellcor, Inc.
FDA 510(k) clearance K904039 for REFLECTANCE SENSOR (RS-10), Substantially Equivalent on 1990-12-27. Applicant: Nellcor, Inc.. Device class: 2.
Clearance details
- Applicant
- Nellcor, 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
- Hayward, CA, 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 Nellcor, Inc.
view all- K953472 — NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
- K952316 — NELLCOR SYMPHONY N-3000 PULSE OXIMETER
- K952222 — NELLCOR N-20PA PORTABLE PULSE OXIMETER
- K942347 — NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000
- K945947 — NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 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 →
Recalls naming K904039
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K904039.
Data sourced from openFDA. This site is unofficial and independent of the FDA.