Holter ECG and ABP System
FDA 510(k) K230184 · Edan Instruments, Inc.
510(k) numberK230184
Submission
- Device name
- Holter ECG and ABP System
- Applicant
- Edan Instruments, Inc.
Shenzhen, CN - Received
- January 23, 2023
- Decision date
- September 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K233906 | S-Patch (S-Patch ExL)DSH · Special | Wellysis Corp. | 02/16/2024SE |
| K231104 | ABPMproDSH · Traditional | Somnomedics GmbH | 11/27/2023SE |
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| K251591 | Holter ECG and ABP system (HolterABP)DQK · Traditional | 02/09/2026SE |
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Questions and answers
When was Holter ECG and ABP System cleared by the FDA?
Holter ECG and ABP System (K230184) received a 510(k) decision of Substantially Equivalent on September 25, 2023, 245 days after the submission was received.
What is the product code of K230184?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.