Cardiocassette II #363
FDA 510(k) K821453 · Birtcher Corp.
510(k) numberK821453
Submission
- Device name
- Cardiocassette II #363
- Applicant
- Birtcher Corp.
Mchenry, IL, US - Received
- May 14, 1982
- Decision date
- May 25, 1982
- 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 |
|---|---|---|
| K881328 | Model 375 ECGDPS · Traditional | 05/18/1988SE |
| K860718 | Electrosurgery Pencil, Model 767GEI · Traditional | 03/24/1986SE |
| K860687 | Birt-A-Switch, DSP Push Button, Model No. 768GEI · Traditional | 03/24/1986SE |
| K854814 | Surgical Cauteries Models 775-11,12,13,31,32 & 33GEI · Traditional | 01/13/1986SE |
| K854864 | Bi-Polar ForcepsGEI · Traditional | 12/24/1985SE |
| K850943 | Model 775 Bipolar CoagulatorGEI · Traditional | 05/20/1985SE |
| K850668 | Electrosurgical Unit 774GEI · Traditional | 05/20/1985SE |
| K844101 | Cardio-Nec Model 365DPS · Traditional | 04/09/1985SE |
| K844104 | Cardio Analyzer Model 380LOS · Traditional | 03/06/1985SE |
| K850297 | Electrosurgical Pencil Holder 720GEI · Traditional | 02/28/1985SE |
Questions and answers
When was Cardiocassette II #363 cleared by the FDA?
Cardiocassette II #363 (K821453) received a 510(k) decision of Substantially Equivalent on May 25, 1982, 11 days after the submission was received.
What is the product code of K821453?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.