FETAL MONITORS, MODELS F2 AND F3— 510(k) K102140
Substantially EquivalentEdan Instruments, Inc.
FDA 510(k) clearance K102140 for FETAL MONITORS, MODELS F2 AND F3, Substantially Equivalent on 2011-01-13. Applicant: Edan Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Edan Instruments, Inc.
- Product code
- Code HGM
- Device class
- Class 2
- Regulation
- 21 CFR 884.2740
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, Guangdong, CN
Recent devices under product code HGM
view allMore clearances from Edan Instruments, Inc.
view all- K251508 — Telemetry Monitor (iT30, iT50)
- 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)
- K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
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 K102140
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102140.
Data sourced from openFDA. This site is unofficial and independent of the FDA.