ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)

K970784 · Alexander Mfg. Co. · DXG · May 14, 1997 · Cardiovascular

Device Facts

Record IDK970784
Device NameALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
ApplicantAlexander Mfg. Co.
Product CodeDXG · Cardiovascular
Decision DateMay 14, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.1435
Device ClassClass 2

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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