CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR

Electrocardiograph

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Cen Sta Mon Ac/dc Alarm Central Acces Alarm Recor.

Pre-market Notification Details

Device IDK863100
510k NumberK863100
Device Name:CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
ClassificationElectrocardiograph
Applicant HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
ContactSteve Brody
CorrespondentSteve Brody
HONEYWELL, INC. ONE CAMPUS DR. Pleasantville,  NY  10570
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-13
Decision Date1987-02-03

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