510(k) K103334
- Device
- CARDIO MED
- Applicant
- CARDIO MEDICAL PRODUCTS, INC.
- 510(k) number
- K103334
- Product code
- LDD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-01-18
- Date received
- 2010-11-15
- Regulation
- 870.5300
- Classification name
- Dc-defibrillator, Low-energy, (including Paddles)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICK MENDISE
- Address
- 385 Franklin Ave. Suite L Rockaway NJ US 07866 07866
FDA Registration Numbers#
- 1220908
- 3017422354
- 1317188
- 3000143502
- 3013596024
- 3004906872
- 3013500228
- 3008717264
- 3010703925
- 1223925
- 3011823740
- 3003615065
- 1320894
- 3030677
- 3012104670
- 3003832357
- 3015876
- 3009077524
- 3004035727
- 3007305485
- 1417592
- 3007029079
- 1066270
- 3015997711
- 3005677568
- 3003072803
- 3010317211
- 3013826848
- 2183890
- 1930027
- 2246340
- 3003800159
- 3013557562
- 8030978
- 3000126629
- 3005521864
Source Documents#
Other 510(k) Records For Product Code LDD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203231 | Switched Internal Paddles | Philips North America, LLC | 2021-01-11 |
| K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | 2020-07-24 |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors | Physio-Control, Inc. | 2019-06-03 |
| K150349 | Rapid Hair Removal Pads | Full Power Aed | 2015-07-14 |
| K140502 | ZOLL E SERIES ALS | ZOLL Medical Corporation | 2014-11-06 |
| K103651 | CARDIOMED | Cardio Medical Products, Inc. | 2011-10-04 |
| K103783 | EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC | Fiab Spa | 2011-06-16 |
| K103159 | CARDIO MED MODEL A102, H104, O101, P103, AND Z100 | Cardio Medical Products, Inc. | 2011-01-11 |
| K102468 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2010-09-30 |
| K100654 | ZOLL PROPAQ MD | Zoll Medical Corporation, World Wide Headquarters | 2010-07-29 |
| K081442 | HEART SYNC PEDIATRIC, MODEL PED-100 | Heart Sync, LLC | 2008-09-24 |
| K081574 | ZOLL R SERIES | ZOLL Medical Corporation | 2008-09-18 |
| K042302 | ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE | Zoll Medical Corp | 2004-10-26 |
| K032691 | ZOLL AUTOCLAVABLE INTERNAL HANDLES | Zoll Medical Corp | 2003-11-13 |
| K030417 | DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES | Philips Medical Systems | 2003-05-09 |
Legacy Summary#
summary
FDA Review#
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