Corvair
FDA 510(k) K231010 · AliveCor, Inc.
510(k) numberK231010
Submission
- Device name
- Corvair
- Applicant
- AliveCor, Inc.
Mountain View, CA, US - Received
- April 7, 2023
- Decision date
- June 7, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code MHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | GE Healthcare Finland Oy | 09/01/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252589 | Corvair MonzaMHX · Traditional | 01/09/2026SE |
| K232035 | ImpalaDPS · Traditional | 06/07/2024SE |
| K220350 | KardiaMobile 6LDXH · Traditional | 05/25/2022SE |
| K212662 | AliveCor QT ServiceDQK · Traditional | 04/26/2022SE |
| K211668 | KardiaMobile CardDXH · Special | 11/30/2021SE |
| K210753 | KardiaMobile 6LDXH · Traditional | 06/30/2021SE |
| K201985 | KardiaAIDQK · Traditional | 11/12/2020SE |
| K191406 | KardiaMobile, KardiaStationDXH · Traditional | 01/24/2020SE |
| K183319 | Triangle SystemDXH · Traditional | 05/10/2019SE |
| K182396 | KardiaMobile, KardiaStationDXH · Traditional | 04/12/2019SE |
Questions and answers
When was Corvair cleared by the FDA?
Corvair (K231010) received a 510(k) decision of Substantially Equivalent on June 7, 2024, 427 days after the submission was received.
What is the product code of K231010?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.