PROCESSOR, K750 COMPUTER/DATA

Calculator/data Processing Module, For Clinical Use

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Processor, K750 Computer/data.

Pre-market Notification Details

Device IDK782052
510k NumberK782052
Device Name:PROCESSOR, K750 COMPUTER/DATA
ClassificationCalculator/data Processing Module, For Clinical Use
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJQP  
CFR Regulation Number862.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-07
Decision Date1979-01-17

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