Fukuda Denshi Co., Ltd.
Shiroi-shi Chiba, JP
FUKUDA DENSHI CO., LTD. appears in FDA device records in Shiroi-shi Chiba, JP. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Fukuda Denshi Co., Ltd. between 2008 and 2011. The busiest year on record is 2008, with 1. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2011 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009607734 | 3009607734 | FUKUDA DENSHI CO., LTD. | 305-1 NAKA, Shiroi-shi Chiba 270-1495 JP | 2026 | and 3 more, listed in full below |
| 9611031 | 3002807019 | FUKUDA DENSHI CO., LTD. | 3-39-4 Hongo, Bunkyo-ku Tokyo 113-8483 JP | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DSKComputer, Blood-Pressure
- DSIDetector And Alarm, Arrhythmia
- FFLDislodger, Stone, Basket, Ureteral, Metal
- DPSElectrocardiograph
- OUGMedical Device Data System
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DQCPhonocardiograph
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- JOOTransducer, Heart Sound
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0203-2018 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required. | For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup). | Class II | Completed |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain