Model Micro Fd+ Ambulatory ECG Monitor
FDA 510(k) K872508 · Advanced Medical Products, Inc.
510(k) numberK872508
Submission
- Device name
- Model Micro Fd+ Ambulatory ECG Monitor
- Applicant
- Advanced Medical Products, Inc.
E. Syracuse, NY, US - Received
- June 24, 1987
- Decision date
- September 25, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
Other 510(k)s with product code DSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260157 | LifeLens Physiological MonitorDSH · Traditional | LifeLens Technologies, Inc. | 07/09/2026SE |
| K252389 | Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)DSH · Traditional | Smwmed, Inc. | 04/23/2026SE |
| K253293 | VitaloJAK Clinic (Model 7100)DSH · Special | Vitalograph , Ltd. | 12/03/2025SE |
| K243650 | Zio® monitor (DFG0001)DSH · Traditional | iRhythm Technologies, Inc. | 08/15/2025SE |
| K243603 | AeviceMDDSH · Traditional | Aevice Health Pte. , Ltd. | 05/05/2025SE |
| K242583 | AT-Patch (ATP-C130/ATP-C70)DSH · Traditional | Atsens Co., Ltd. | 05/02/2025SE |
| K232670 | HiCardi+ H100DSH · Traditional | MEZOO Co., Ltd. | 09/20/2024SE |
| K233906 | S-Patch (S-Patch ExL)DSH · Special | Wellysis Corp. | 02/16/2024SE |
| K231104 | ABPMproDSH · Traditional | Somnomedics GmbH | 11/27/2023SE |
| K233110 | Carnation Ambulatory MonitorDSH · Traditional | Bardy Diagnostics, Inc. | 11/22/2023SE |
More from Bardy Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000932 | Arachnophlebectomy NeedleGAH · Traditional | 05/17/2000SE |
| K923995 | Urodynamics Tubing Kits #5161, #5150, #7170FAP · Traditional | 04/08/1993SE |
| K921426 | Ultra PciIYO · Traditional | 10/05/1992SE |
| K912925 | Ultra PVDJAF · Traditional | 06/18/1992SE |
| K915658 | Spectra ECGLOS · Traditional | 06/10/1992SE |
| K896103 | Micro FL 7400 Ambulatory Holter/Bp MonitorDSI · Traditional | 01/18/1990SE |
| K896102 | Micro FD 7000 Ambulatory Blood Pressure MonitorDXN · Traditional | 01/18/1990SE |
| K881905 | Model Micro Si Ambulatory ECG MonitorDSI · Traditional | 08/02/1988SE |
| K870538 | Model 192 PrinterDSF · Traditional | 04/23/1987SE |
| K870537 | Model Micro ST Ambulatory ECG MonitorDSH · Traditional | 04/23/1987SE |
Questions and answers
When was Model Micro Fd+ Ambulatory ECG Monitor cleared by the FDA?
Model Micro Fd+ Ambulatory ECG Monitor (K872508) received a 510(k) decision of Substantially Equivalent on September 25, 1987, 93 days after the submission was received.
What is the product code of K872508?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.