Devices

Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure.

Model / Serial
Software version V04.00.02 was shipped on 06/30/2008. The 92810 is a software application installed on an off-the-shelf computer and is not serialized. Spacelabs uses software versions and ship dates for identification and traceability purposes.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US, Turkey, Chile, Brazil, Netherlands, Puerto Rico, Switzerland, Australia, Czech Republic, Canada, Italy, Singapore, France, Germany, and Israel.
Product Description
Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. || The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. || Standard reports are available from Smart Disclosure, including saved events, disclosure, trends histogram and summary.
Manufacturer
Spacelabs Healthcare, Incorporated
1 Event
- Recall of Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure.

Manufacturer

Spacelabs Healthcare, Incorporated

Manufacturer Address
Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
Source
USFDA

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