Aulisa Multiple Patient Digital Vital Sign Monitoring System— 510(k) K202497
Substantially EquivalentTaiwan Aulisa Medical Devices Technologies, Inc.
FDA 510(k) clearance K202497 for Aulisa Multiple Patient Digital Vital Sign Monitoring System, Substantially Equivalent on 2020-10-30. Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc.
- Product code
- Code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, TW
Recent devices under product code MSX
view allMore 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
- K191207 — Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
Adverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
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.