Dc-Defibrillator, High Energy, (Including Paddles)
The DC Defibrillator (High Energy, Including Paddles) is a cardiovascular resuscitation device used to deliver a high-energy electrical shock to the heart in order to terminate life-threatening arrhythmias such as ventricular fibrillation or ventricular tachycardia. It is classified as an FDA Class 3 device, the highest risk category, and requires Premarket Approval (PMA) before marketing. The product code is DRK and it is regulated under 21 CFR 870.5300 within the Cardiovascular medical specialty. A PMA was required to be filed by 12/26/96 (61 FR 50706).
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Basic Information
- Product Code
- DRK
- Device Class
- FDA class 3
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934067 | POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 | Oct 07, 1993 | Substantially Equivalent | National Custom Ent., Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.