Monark 869 Ergometer
FDA 510(k) K855102 · Equilibrated Bio Systems, Inc.
510(k) numberK855102
Submission
- Device name
- Monark 869 Ergometer
- Applicant
- Equilibrated Bio Systems, Inc.
Melville, NY, US - Received
- December 23, 1985
- Decision date
- May 9, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3535
- Specialty
- Cardiovascular
Other 510(k)s with product code DSP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250542 | AC3 Range Intra-Aortic Balloon PumpDSP · Special | Arrow International, LLC | 03/26/2025SE |
| K232343 | AC3 Series IABPDSP · Special | Arrow International, LLC | 08/30/2023SE |
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special | Arrow International, Inc. | 05/27/2020SE |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special | Arrow International, Inc. | 04/09/2020SE |
| K192238 | AC3 Series Intra-Aortic Balloon Pump (IABP)DSP · Special | Arrow International, Teleflex | 11/12/2019SE |
| K190101 | UltraFlex IABDSP · Traditional | Arrow International, Inc. | 06/28/2019SE |
| K190117 | Fiberoptix IABDSP · Traditional | Arrow International, Inc. | 06/13/2019SE |
| K181122 | CARDIOSAVE Intra-Aortic Balloon PumpDSP · Special | Datascope Corp. | 05/31/2018SE |
| K172305 | CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP · Special | Datascope Corp. | 10/12/2017SE |
| K162820 | AC3 Series IABP SystemDSP · Traditional | Arrow International, Inc. | 03/31/2017SE |
More from Arrow International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K892705 | EBS2605 Infant HuggerBTY · Traditional | 10/27/1989SE |
| K843996 | Turboaire Challanger Environmental Air ControllerBZG · Traditional | 11/20/1984SE |
| K791294 | SpirocalBXX · Traditional | 08/16/1979SE |
| K790410 | Adult Zee-FrameJAY · Traditional | 03/22/1979SE |
| K781509 | Zee-FrameJAY · Traditional | 09/26/1978SE |
| K781386 | Ebs 775 TonometerLCH · Traditional | 09/14/1978SE |
Questions and answers
When was Monark 869 Ergometer cleared by the FDA?
Monark 869 Ergometer (K855102) received a 510(k) decision of Substantially Equivalent on May 9, 1986, 137 days after the submission was received.
What is the product code of K855102?
The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.