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510(k) K881885

Device
BATTERY PACKS (OTHER THAN CV)
Applicant
DOWIT SERVICE CO., INC.
510(k) number
K881885
Product code
FCP  
Decision
Substantially Equivalent (SESE)
Decision date
1988-07-26
Date received
1988-05-04
Regulation
876.1500
Classification name
Box, Battery, Pocket
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOAN POTOSNAK
Address
10 Valhalla Rd. Montville NJ US 07045 07045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FCP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K891927TELEMETRY POWER PACK MODEL 2Lucas & Rhea Mfg.1990-04-26

Legacy Summary#

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FDA Review#

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