Pace *Aid
FDA 510(k) K813553 · Cardiac Resucitator Corp.
510(k) numberK813553
Submission
- Device name
- Pace *Aid
- Applicant
- Cardiac Resucitator Corp.
Mchenry, IL, US - Received
- December 22, 1981
- Decision date
- January 18, 1982
- 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 |
|---|---|---|
| K882513 | Modified Heart*Aid 97 Auto. External DefibrillatorDSI · Traditional | 07/12/1988SE |
| K871971 | Modified Pace*Aid Model 53DRO · Traditional | 06/24/1987SE |
| K871538 | Stat-Pad (TM)DRO · Traditional | 06/24/1987SE |
| K871569 | Modified Heart*Aid 97 Auto. External DefibrillatorDRO · Traditional | 06/08/1987SE |
| K870622 | Heart*Aid 1000MKJ · Traditional | 04/10/1987SE |
| K850596 | Pace*Aid 10 a -Pad 10A- Pacemaker Output Display &DRO · Traditional | 03/06/1985SE |
| K850170 | Heart Aid Model 97DRO · Traditional | 02/14/1985SE |
| K844811 | Pace Aid Model 53DRO · Traditional | 01/24/1985SE |
| K843547 | Pace *Aid Model 52DRO · Traditional | 12/17/1984SE |
| K843358 | Heart-Aid Model 80DRO · Traditional | 11/19/1984SE |
Questions and answers
When was Pace *Aid cleared by the FDA?
Pace *Aid (K813553) received a 510(k) decision of Substantially Equivalent on January 18, 1982, 27 days after the submission was received.
What is the product code of K813553?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.