HEARTSTREAMFR2 AED with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A
FDA 510(k) K014157 · Philips Medical Systems
Submission
- Device name
- HEARTSTREAMFR2 AED with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A
- Applicant
- Philips Medical Systems
Seattle, WA, US - Received
- December 19, 2001
- Decision date
- January 17, 2002
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Special 510(k)
Device classification
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Specialty
- Cardiovascular
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is…
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Questions and answers
When was HEARTSTREAMFR2 AED with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A cleared by the FDA?
HEARTSTREAMFR2 AED with M3848A and M3849A, Models M3860A, M3861, M3840A, M3841A (K014157) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on January 17, 2002, 29 days after the submission was received.
What is the product code of K014157?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.