CARDIO MED MODEL A102, H104, O101, P103, AND Z100— 510(k) K103159
Substantially EquivalentCardio Medical Products, Inc.
FDA 510(k) clearance K103159 for CARDIO MED MODEL A102, H104, O101, P103, AND Z100, Substantially Equivalent on 2011-01-11. Applicant: Cardio Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardio Medical Products, Inc.
- Product code
- Code LDD
- Device class
- Class 2
- Regulation
- 21 CFR 870.5300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockaway, NJ, US
Recent devices under product code LDD
view allMore clearances from Cardio Medical Products, Inc.
view allAdverse events under product code LDD
product code LDD- Death
- 38
- Malfunction
- 522
- 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 →
Recalls naming K103159
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103159.
Data sourced from openFDA. This site is unofficial and independent of the FDA.