Model #918 Multi-Pads
FDA 510(k) K883375 · Cardiotronics, Inc.
510(k) numberK883375
Submission
- Device name
- Model #918 Multi-Pads
- Applicant
- Cardiotronics, Inc.
West Carlsbad, CA, US - Received
- August 9, 1988
- Decision date
- August 30, 1988
- 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 |
More from Physio-Control Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K932903 | EKG VestDRX · Traditional | 02/24/1995SE |
| K922064 | Model #510 Stealth-Plate Dispersive ElectrodeGXD · Traditional | 12/01/1992SE |
| K923297 | Model #340 Stealth-Trode+LsLDD · Traditional | 09/18/1992SE |
| K922227 | Model #225-ST Shock-Trode Adult Defib Pads SterileLDD · Traditional | 06/11/1992SE |
| K922173 | Model # 830 ST Adult Stimulation Pads (Sterile)LDD · Traditional | 06/11/1992SE |
| K922172 | Model # 230 ST Stealth-Trode Defib Pads (Sterile)LDD · Traditional | 06/11/1992SE |
| K921606 | Model #125 Child Stimulation PadsLDD · Traditional | 05/26/1992SE |
| K920086 | Shock-Patch Adult Defibrillation PadsLDD · Traditional | 02/03/1992SE |
| K914725 | Coordinator, Cable InputDPS · Traditional | 11/05/1991SE |
| K912621 | Model #911 Stealth Multi PadsLDD · Traditional | 10/16/1991SE |
Questions and answers
When was Model #918 Multi-Pads cleared by the FDA?
Model #918 Multi-Pads (K883375) received a 510(k) decision of Substantially Equivalent on August 30, 1988, 21 days after the submission was received.
What is the product code of K883375?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.