CARDICARE MODEL MT-301F & MT-301C— 510(k) K032714
Substantially EquivalentLumiscope Co., Inc.
FDA 510(k) clearance K032714 for CARDICARE MODEL MT-301F & MT-301C, Substantially Equivalent on 2003-10-22. Applicant: Lumiscope Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Lumiscope Co., Inc.
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Brunswick, NJ, US
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More clearances from Lumiscope Co., Inc.
view allAdverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
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.