Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)— 510(k) K252821
Substantially EquivalentPhilips Medizin Systeme Böblingen GmbH
FDA 510(k) clearance K252821 for Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T), Substantially Equivalent on 2026-05-29. Applicant: Philips Medizin Systeme Böblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Böblingen GmbH
- 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
- Böblingen, DE
Recent devices under product code DQA
view all- 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)
- K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
More clearances from Philips Medizin Systeme Böblingen GmbH
view all- K253654 — IntelliVue Measurement Rack 6000 (867317)
- K251702 — IntelliVue Patient Monitor MX750 +2 more
- K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
- K242962 — Telemetry Monitor 5500 Release 4.0 (867232)
- K241890 — Philips Holter Analysis System
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.