SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY

Pulse-generator, Pacemaker, External

SEAMED CORP.

The following data is part of a premarket notification filed by Seamed Corp. with the FDA for Seamed Model 3300 Dual Chamber Pacing System Analy.

Pre-market Notification Details

Device IDK883930
510k NumberK883930
Device Name:SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
ClassificationPulse-generator, Pacemaker, External
Applicant SEAMED CORP. 11810 NORTH CREEK PKWY. NORTH Bothell,  WA  98011
ContactMarcia A W.-page
CorrespondentMarcia A W.-page
SEAMED CORP. 11810 NORTH CREEK PKWY. NORTH Bothell,  WA  98011
Product CodeDTE  
CFR Regulation Number870.3600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-15
Decision Date1988-11-09

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