ECG CABLES, TRUNK AND PATIENT LEAD WIRES— 510(k) K070232
Substantially EquivalentAmerican I.V. Products, Inc.
FDA 510(k) clearance K070232 for ECG CABLES, TRUNK AND PATIENT LEAD WIRES, Substantially Equivalent on 2007-03-27. Applicant: American I.V. Products, Inc.. Device class: 2.
Clearance details
- Applicant
- American I.V. Products, Inc.
- Product code
- Code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Harmans, MD, US
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More clearances from American I.V. Products, Inc.
view all- K120209 — PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
- K070342 — CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
- K052544 — PULSE OXIMETER ADAPTER CABLES
- K040392 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
- K040819 — TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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.