V2
FDA 510(k) K970481 · Survivalink Corp.
510(k) numberK970481
Submission
- Device name
- V2
- Applicant
- Survivalink Corp.
Minnetonka, MN, US - Received
- February 10, 1997
- Decision date
- July 1, 1997
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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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| K203231 | Switched Internal PaddlesLDD · Special | Philips North America, LLC | 01/11/2021SE |
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| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD · Traditional | Physio-Control, Inc. | 06/03/2019SE |
| K150349 | Rapid Hair Removal PadsLDD · Traditional | Full Power Aed | 07/14/2015SE |
| K140502 | Zoll E Series AlsLDD · Traditional | ZOLL Medical Corporation | 11/06/2014SE |
| 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 |
|---|---|---|
| K011901 | Firstsave Star Biphasic, Model 9210/9200MKJ · Traditional | 02/01/2002SE |
| K010214 | Firstsave Biphasic Model #9200 and 9210MKJ · Special | 02/22/2001SE |
| K993072 | Survivalink Multifunctional Electrode (SVL-9630)MKJ · Traditional | 12/10/1999SE |
| K982264 | Firstsave Biphasic Models 9200 and 9210MKJ · Traditional | 01/25/1999ST |
| K971149 | SVL-9130 Defibrillation ElectrodeMKJ · Traditional | 06/23/1997SE |
| K940445 | Vivalink AED DefibrillatorMKJ · Traditional | 02/09/1995SE |
Questions and answers
When was V2 cleared by the FDA?
V2 (K970481) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on July 1, 1997, 141 days after the submission was received.
What is the product code of K970481?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.