Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System— 510(k) K182822
Substantially EquivalentTaiwan Aulisa Medical Devices Technologies, Inc.
FDA 510(k) clearance K182822 for Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System, Substantially Equivalent on 2019-03-01. Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Taiwan Aulisa Medical Devices Technologies, 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
- Taipei, TW
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 Taiwan Aulisa Medical Devices Technologies, Inc.
view all- K233963 — Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
- K233956 — Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
- K240220 — Aulisa Temperature Module (TM0002)
- K203208 — Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
- K202497 — Aulisa Multiple Patient Digital Vital Sign Monitoring 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.