SYSTEM 7300 PULSE OXIMETER— 510(k) K910521
Substantially EquivalentAdvanced Medical Instruments, Inc.
FDA 510(k) clearance K910521 for SYSTEM 7300 PULSE OXIMETER, Substantially Equivalent on 1991-04-18. Applicant: Advanced Medical Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Medical Instruments, 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
- Broken Arrow, OK, US
Recent devices under product code DQA
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- K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
- K252448 — AViTA Pulse Oximeter (SP61)
More clearances from Advanced Medical Instruments, Inc.
view allAdverse 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.