DC200 Defibrillator
FDA 510(k) K910634 · Siemens Burdick, Inc.
510(k) numberK910634
Submission
- Device name
- DC200 Defibrillator
- Applicant
- Siemens Burdick, Inc.
Miltoon, WI, US - Received
- February 13, 1991
- Decision date
- July 24, 1991
- 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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| 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 |
|---|---|---|
| K915327 | Elite II Electrocardiograph,ModifiedLOS · Traditional | 10/09/1992SE |
| K915225 | MegacartLOS · Traditional | 07/01/1992SE |
| K915202 | Internal Modem for the E560 ElectrocardiographLOS · Traditional | 05/15/1992SE |
| K914969 | E350I ElectrocardiographLOS · Traditional | 03/26/1992SE |
| K913518 | TA620 Treadmill ControllerIOL · Traditional | 10/24/1991SE |
| K910867 | T600 TreadmillIOL · Traditional | 05/31/1991SE |
Questions and answers
When was DC200 Defibrillator cleared by the FDA?
DC200 Defibrillator (K910634) received a 510(k) decision of Substantially Equivalent on July 24, 1991, 161 days after the submission was received.
What is the product code of K910634?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.