HeartStart FRx Defibrillator
FDA premarket approval P180028 · decided 2020-05-11
Approval details
- PMA number
- P180028
- Trade name
- HeartStart FRx Defibrillator
- Generic name
- Automated external defibrillators (non-wearable)
- Applicant
- Philips Medical Systems
- Date received
- 2018-08-03
- Decision date
- 2020-05-11
- Days to decision
- 647 days
- Decision code
- APPR
- Product code
- MKJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- Approval for the HeartStart FRx Defibrillator (Model 861304). The device is indicated for use on potential victims of sudden cardiac arrest (SCA) with the following symptoms:1) Unconsciousness; and2) Absence of normal breathingThe HeartStart FRx (Model 861304) is indicated for adults over 55 pounds (25 kg). The Model 861304 is also indicated for infants and children under 55 pounds (25 kg) or 0-8 years old when used with the optional Infant/Child Key (Model 989803139311). If the Infant/Child Key
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510(k) clearances by this applicant
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