Dispos Gel External Pacing Electrode/Hi Impedance
FDA 510(k) K864987 · Medac, Inc.
510(k) numberK864987
Submission
- Device name
- Dispos Gel External Pacing Electrode/Hi Impedance
- Applicant
- Medac, Inc.
Tualatin, OR, US - Received
- December 22, 1986
- Decision date
- March 3, 1987
- 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 |
|---|---|---|
| K874319 | Monitor, ElectrographicDRT · Traditional | 03/07/1988SE |
| K874447 | Disposable Gel Defibrillation/External Pacing ElecDRO · Traditional | 01/27/1988SE |
| K874090 | 300M ECG Monitro/Transcutaneous PacemakerDRO · Traditional | 12/15/1987SE |
| K874091 | 360D DC DefibrillatorLDD · Traditional | 11/23/1987SE |
| K871176 | Pace 10 Non-Invasive External PacemakerDRO · Traditional | 04/23/1987SE |
| K864985 | Dispos Gel External Pacing Electrode/Low ImpedanceDRO · Traditional | 03/10/1987SE |
| K864989 | Etp 180A Non-Invasive External PacemakerDRO · Traditional | 03/03/1987SE |
| K864988 | Etp 180E Non-Invasive External PacemakerDRO · Traditional | 03/03/1987SE |
| K864986 | Etp 300 Non-Invasive External PacemakerDRO · Traditional | 03/03/1987SE |
Questions and answers
When was Dispos Gel External Pacing Electrode/Hi Impedance cleared by the FDA?
Dispos Gel External Pacing Electrode/Hi Impedance (K864987) received a 510(k) decision of Substantially Equivalent on March 3, 1987, 71 days after the submission was received.
What is the product code of K864987?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.