OxSAT 100— 510(k) K191574
Substantially EquivalentS.L.P. , Ltd.
FDA 510(k) clearance K191574 for OxSAT 100, Substantially Equivalent on 2020-04-09. Applicant: S.L.P. , Ltd.. Device class: 2.
Clearance details
- Applicant
- S.L.P. , Ltd.
- 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
- Tel-Aviv, IL
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More clearances from S.L.P. , Ltd.
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.