360D DC Defibrillator
FDA 510(k) K874091 · Medac, Inc.
510(k) numberK874091
Submission
- Device name
- 360D DC Defibrillator
- Applicant
- Medac, Inc.
Tualatin, OR, US - Received
- October 7, 1987
- Decision date
- November 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K150349 | Rapid Hair Removal PadsLDD · Traditional | Full Power Aed | 07/14/2015SE |
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| K103651 | CardiomedLDD · Traditional | Cardio Medical Products, Inc. | 10/04/2011SE |
| K103783 | Euro Defi Pads Adult; Euro Defi Pads Adult Radiotransparent: Euro Defi Pads PediatricLDD · Traditional | Fiab Spa | 06/16/2011SE |
| K103334 | Cardio MedLDD · Traditional | Cardio Medical Products, Inc. | 01/18/2011SE |
| K103159 | Cardio Med Model A102, H104, O101, P103, and Z100LDD · Traditional | Cardio Medical Products, Inc. | 01/11/2011SE |
| K102468 | Zoll Propaq MDLDD · Special | Zoll Medical Corporation, World Wide Headquarters | 09/30/2010SE |
More from Zoll Medical Corporation, World Wide Headquarters
| 510(k) | Device | Decision |
|---|---|---|
| K874319 | Monitor, ElectrographicDRT · Traditional | 03/07/1988SE |
| K874447 | Disposable Gel Defibrillation/External Pacing ElecDRO · Traditional | 01/27/1988SE |
| K874090 | 300M ECG Monitro/Transcutaneous PacemakerDRO · Traditional | 12/15/1987SE |
| K871176 | Pace 10 Non-Invasive External PacemakerDRO · Traditional | 04/23/1987SE |
| K864985 | Dispos Gel External Pacing Electrode/Low ImpedanceDRO · Traditional | 03/10/1987SE |
| K864989 | Etp 180A Non-Invasive External PacemakerDRO · Traditional | 03/03/1987SE |
| K864988 | Etp 180E Non-Invasive External PacemakerDRO · Traditional | 03/03/1987SE |
| K864987 | Dispos Gel External Pacing Electrode/Hi ImpedanceDRO · Traditional | 03/03/1987SE |
| K864986 | Etp 300 Non-Invasive External PacemakerDRO · Traditional | 03/03/1987SE |
Questions and answers
When was 360D DC Defibrillator cleared by the FDA?
360D DC Defibrillator (K874091) received a 510(k) decision of Substantially Equivalent on November 23, 1987, 47 days after the submission was received.
What is the product code of K874091?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.