MRL Pacette, 450SLL
FDA 510(k) K880932 · Medical Research Laboratories, Inc.
510(k) numberK880932
Submission
- Device name
- MRL Pacette, 450SLL
- Applicant
- Medical Research Laboratories, Inc.
Niles, IL, US - Received
- March 7, 1988
- Decision date
- December 16, 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
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| 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 |
|---|---|---|
| K021168 | Jump Start, Model 970300MKJ · Traditional | 06/26/2002ST |
| K012766 | Portable Intensive Care UnitMKJ · Traditional | 01/23/2002ST |
| K012030 | Portable Intensive Care UnitMKJ · Traditional | 09/24/2001SE |
| K010207 | Portable Instensive Care UnitMKJ · Special | 06/14/2001ST |
| K002232 | AedefibrillatorMKJ · Traditional | 12/06/2000SE |
| K000712 | Portable Intensive Care Unit, Model PicCCK · Special | 04/27/2000SE |
| K983307 | Modification to Portable Intensive Care UnitMKJ · Special | 11/20/1998SE |
| K974034 | Portable Intensive Care UnitDRO · Traditional | 03/02/1998SE |
| K952085 | DPD DefibrillatorLDD · Traditional | 06/05/1995ST |
| K935922 | 360 SLX Advisory DefibrillatorMKJ · Traditional | 12/22/1994SE |
Questions and answers
When was MRL Pacette, 450SLL cleared by the FDA?
MRL Pacette, 450SLL (K880932) received a 510(k) decision of Substantially Equivalent on December 16, 1988, 284 days after the submission was received.
What is the product code of K880932?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.