Defib/Pacing Pads
FDA 510(k) K894588 · Conmedcorp
510(k) numberK894588
Submission
- Device name
- Defib/Pacing Pads
- Applicant
- Conmedcorp
Utica, NY, US - Received
- July 24, 1989
- Decision date
- October 26, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5550
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012404 | K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional | Katecho, Inc. | 10/12/2001SE |
| K012218 | Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesDRO · Traditional | The Ludlow Company LP | 10/12/2001SE |
| K000660 | Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special | Medical Data Electronics | 03/28/2000SE |
| K983232 | Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K983196 | Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K974034 | Portable Intensive Care UnitDRO · Traditional | Medical Research Laboratories, Inc. | 03/02/1998SE |
| K962547 | Cardioserv PDRO · Traditional | Marquette Electronics, Inc. | 03/06/1997SE |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | Marquette Electronics, Inc. | 02/28/1997SE |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | Medical Data Electronics | 12/10/1996SE |
| K951593 | Lifepak 11DRO · Traditional | Physio-Control Corp. | 12/29/1995SE |
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| K021079 | Abcsnare Electrosurgical Probe for Flexible Endoscopes, Model 1336XXGEI · Traditional | 07/01/2002SE |
| K021299 | Conmed Heatwave Hand-Controlled EletrodeGEI · Traditional | 06/26/2002SE |
| K020186 | Conmed System 5000 EsuGEI · Traditional | 04/12/2002SE |
| K020135 | Conmed System 2000 Electrosurgical Generator, Ref: 60-8002; Conmed Esu Cart, Ref: 60-6120GEI · Traditional | 04/12/2002SE |
Questions and answers
When was Defib/Pacing Pads cleared by the FDA?
Defib/Pacing Pads (K894588) received a 510(k) decision of Substantially Equivalent on October 26, 1989, 94 days after the submission was received.
What is the product code of K894588?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.