PATIENT MONITOR— 510(k) K113653
Substantially EquivalentEdan Instruments, Inc.
FDA 510(k) clearance K113653 for PATIENT MONITOR, Substantially Equivalent on 2012-02-06. Applicant: Edan Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Edan Instruments, Inc.
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code MHX
view allMore clearances from Edan Instruments, Inc.
view all- K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- K251591 — Holter ECG and ABP system (HolterABP)
- K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
- K241882 — Fetal & Maternal Monitor (F15A, F15A Air)
- K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K113653
K-number listed on FDA's recall record- Z-1154-2026 — Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP. The above is the maximum configuration, the user may select different monitoring parameters in according with the requirement. iM8 Series patient monitor includes three models iM8, iM8A, iM8B, and screen size is the primary difference for three models. Component: No
- Z-2388-2016 — EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113653.
Data sourced from openFDA. This site is unofficial and independent of the FDA.