510(k) K834585

CELLTRAK-B by R&D Systems, Inc. — Product Code FRZ

K834585 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "CELLTRAK-B". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code FRZ (Device, Patient Transfer, Powered), a Class II device regulated under 21 CFR 880.6775. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.