Firstsave Biphasic Models 9200 and 9210
FDA 510(k) K982264 · Survivalink Corp.
Submission
- Device name
- Firstsave Biphasic Models 9200 and 9210
- Applicant
- Survivalink Corp.
Minnetonka, MN, US - Received
- June 29, 1998
- Decision date
- January 25, 1999
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 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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More from Leonhard Lang GmbH
| 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 |
| K970481 | V2LDD · Traditional | 07/01/1997ST |
| K971149 | SVL-9130 Defibrillation ElectrodeMKJ · Traditional | 06/23/1997SE |
| K940445 | Vivalink AED DefibrillatorMKJ · Traditional | 02/09/1995SE |
Questions and answers
When was Firstsave Biphasic Models 9200 and 9210 cleared by the FDA?
Firstsave Biphasic Models 9200 and 9210 (K982264) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on January 25, 1999, 210 days after the submission was received.
What is the product code of K982264?
The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.