Devices

Device Recall pcFM Software Kit

Model / Serial
Model 6830 ComboMap Software kit; Kit P/N #'s: 803259001; 806431005; S2000061, 806431002.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) including states of: CA, MI, TX, and WI; and countries of: The Netherlands, Sweden and United Kingdom.
Product Description
Volcano pcFM Software Kit ; || Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624. || The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data.
Manufacturer
Volcano Corporation
1 Event
- Recall of Device Recall pcFM Software Kit

Manufacturer

Volcano Corporation

Manufacturer Address
Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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