Zoll Propaq MD
FDA 510(k) K100654 · Zoll Medical Corporation, World Wide Headquarters
510(k) numberK100654
Submission
- Device name
- Zoll Propaq MD
- Applicant
- Zoll Medical Corporation, World Wide Headquarters
Chelsmford, MA, US - Received
- March 8, 2010
- Decision date
- July 29, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
|---|---|---|
| K133239 | Zoll E SeriesMKJ · Traditional | 01/16/2015SE |
| K133269 | Zoll X SeriesMKJ · Traditional | 05/22/2014SE |
| K120406 | Zoll Fully Automatic AED PlusMKJ · Traditional | 10/26/2012SE |
| K120907 | Zoll R SeriesMKJ · Traditional | 09/25/2012SE |
| K112761 | Zoll Propaq MDMKJ · Traditional | 04/25/2012SE |
| K112432 | Zoll X SeriesMKJ · Traditional | 03/21/2012SE |
| K111296 | Zoll RescuenetlinkMSX · Traditional | 10/27/2011SE |
| K111594 | Zoll E SeriesMKJ · Traditional | 08/17/2011SE |
| K110361 | Zoll R Series with 2010 Aha Guidelines Software UpdateMKJ · Special | 03/08/2011SE |
| K110168 | Zoll E Series with 2010 Aha Guidlines Software UpdateMKJ · Special | 02/17/2011SE |
Questions and answers
When was Zoll Propaq MD cleared by the FDA?
Zoll Propaq MD (K100654) received a 510(k) decision of Substantially Equivalent on July 29, 2010, 143 days after the submission was received.
What is the product code of K100654?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.