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510(k) K861981

Device
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
Applicant
VITAL SIGNS, INC.
510(k) number
K861981
Product code
DRW  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-25
Date received
1986-05-22
Regulation
870.2350
Classification name
Adaptor, Lead Switching, Electrocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CRAIG CITRON
Address
20 Campus Rd. Totowa NJ US 07512 07512

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K033513EASI ECG ALGORITHMPhilips Medical Systems2004-01-15
K020456EASI 12 LEAD ALGORITHMPhilips Medical Systems2002-07-09
K930786EPCORSiemens Medical Solutions USA, Inc.1994-09-26
K872781EASI LEAD SYSTEM CABLE ASSEMBLYTotemite Medical Electronics1987-12-29
K851627KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTREaton Medical Group1985-11-08
K851632PCX-100 PATIENT INPUT LEADWIREEaton Medical Group1985-11-08
K761210LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)Physio-Control Corp.1976-12-21

Legacy Summary#

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FDA Review#

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