SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM

Computer, Diagnostic, Pre-programmed, Single-function

SPECTRAMED, INC.

The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Spectramed Model Sp1455 Hemopro2 System.

Pre-market Notification Details

Device IDK865101
510k NumberK865101
Device Name:SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant SPECTRAMED, INC. 2530 PENNSYLVANIA AVENUE SOUTH St. Louis Park,  MN  55426
ContactFreedman, Phd
CorrespondentFreedman, Phd
SPECTRAMED, INC. 2530 PENNSYLVANIA AVENUE SOUTH St. Louis Park,  MN  55426
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-30
Decision Date1987-04-20

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