FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS— 510(k) K100797
Substantially EquivalentEdan Instruments, Inc.
FDA 510(k) clearance K100797 for FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS, Substantially Equivalent on 2010-11-10. 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
- Great Neck, NY, US
Recent devices under product code HGM
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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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.