HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
FDA premarket approval P160029 · decided 2019-06-06
Approval details
- PMA number
- P160029
- Trade name
- HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
- Generic name
- Over-the-counter automated external defibrillator
- Applicant
- Philips Medical Systems, Inc.
- Date received
- 2016-07-29
- Decision date
- 2019-06-06
- Days to decision
- 1042 days
- Decision code
- APPR
- Product code
- NSA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- Approval for the HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A). The HeartStart OnSite Defibrillator (M5066A) is indicated for use on potential victims of sudden cardiac arrest with the following symptoms:1) Unconsciousness; and 2) Absence of normal breathing.The HeartStart OnSite (Model M5066A) is indicated for adults over 55 pounds (25 kg). It is also indicated for infants and children under 55 lbs (25 kg) or 8 years old when used with the optio
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PCR ELEVA 1.2 (K093355) | Philips Medical Systems, Inc. | 2010-01-08 |
| PINNACLE3 SMARTARC (K090808) | Philips Medical Systems, Inc. | 2009-04-03 |
| PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 (K071391) | Philips Medical Systems, Inc. | 2007-09-07 |
| PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A (K063783) | Philips Medical Systems, Inc. | 2007-04-27 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN (K041741) | Philips Medical Systems, Inc. | 2004-07-21 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN (K040955) | Philips Medical Systems, Inc. | 2004-05-12 |
| HEARTSTART MRX, MODEL M3535A (K040404) | Philips Medical Systems, Inc. | 2004-05-04 |
| M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II (K040357) | Philips Medical Systems, Inc. | 2004-03-03 |