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510(k) K901332

Device
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
Applicant
BIOTRONIK, GMBH & CO.
510(k) number
K901332
Product code
DTC  
Decision
Substantially Equivalent (SESE)
Decision date
1990-05-09
Date received
1990-03-22
Regulation
870.3630
Classification name
Analyzer, Pacemaker Generator Function
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STOUT, MD
Address
6024 Southwest Jean Rd. Unit B4 Lake Oswego OR US 97035 97035

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DTC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170815PSA CableBoston Scientific Corporation2017-07-06
K083674PK-141 PATIENT CABLEBiotronik, Inc.2009-04-01
K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, Inc.2001-08-30
K002497MODEL 4810 ANALYZER OUTPUT ADAPTERPace Medical2000-10-10
K961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.1996-11-08
K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, Inc.1991-06-19
K910595MODEL 5311B A-V PACING SYSTEM ANALYZERMedtronic Vascular1991-05-07
K910223CPI MODEL 2215/SEAMED MODEL 3400Seamed Corp.1991-03-19
K896632MEDTRONIC MODEL 5401B TEST CABLEMedtronic Vascular1989-12-13
K884331MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZERMedtronic Vascular1989-01-10
K882327PACER SENSING ANALYZER (PSA 100)Oscor Medical Corp.1988-10-06
K860462SEAMED MODEL 3000Seamed Corp.1986-08-19
K851900SEA MED DDD PACING SYSTEM ANALYZERSeamed Corp.1985-07-19
K850077MEDTRONIC 5311 PACING SYSTEM ANALYZERMedtronic Vascular1985-07-16
K844969CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)Cordis Corp.1985-05-01

Legacy Summary#

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FDA Review#

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