SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP— 510(k) K043204
Substantially EquivalentSgarlato Laboratories, Inc.
FDA 510(k) clearance K043204 for SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP, Substantially Equivalent on 2005-03-30. Applicant: Sgarlato Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Sgarlato Laboratories, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campbell, CA, US
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More clearances from Sgarlato Laboratories, Inc.
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.