PERSONAL DEFIBRILLATOR— 510(k) K832833
Substantially EquivalentPhysio-Control, Inc.
FDA 510(k) clearance K832833 for PERSONAL DEFIBRILLATOR, Substantially Equivalent on 1984-10-26. Applicant: Physio-Control, Inc.. Device class: 2.
Clearance details
- Applicant
- Physio-Control, 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
- Redmond, WA, US
Recent devices under product code LDD
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view all- K253099 — LIFEPAK 15 AC Power Adapter (41577-000333)
- K240156 — LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021) +1 more
- K142430 — LIFEPAK 15 monitor/defibrillator
- K130454 — LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
- K123597 — TRUECPR COACHING DEVICE
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.