OMF-7101 FETAL MONITOR— 510(k) K860237
Substantially EquivalentNihon Kohden America, Inc.
FDA 510(k) clearance K860237 for OMF-7101 FETAL MONITOR, Substantially Equivalent on 1986-09-05. Applicant: Nihon Kohden America, Inc.. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden America, 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
- Irvine, CA, US
Recent devices under product code HGM
view allMore clearances from Nihon Kohden America, Inc.
view all- K113117 — NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
- K120485 — NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
- K092573 — NIHON KOHDEN QP-160AK EEG TREND PROGRAM
- K083456 — NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
- K083271 — BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
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.