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510(k) K971240

Device
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
Applicant
ALEXANDER MFG. CO.
510(k) number
K971240
Product code
HEL  
Decision
Substantially Equivalent (SESE)
Decision date
1997-06-06
Date received
1997-04-02
Regulation
884.2660
Classification name
Monitor, Heart Rate, Fetal, Ultrasonic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KEN HEIMENDINGER
Address
1511 S Garfield Pl. Mason City IA US 50401 50401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HEL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003876US SENSOR #CG-930P; TOCO SENSOR CG-940PCard Guard Scientific Survival , Ltd.2001-07-09
K010920TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGMedical Cables, Inc.2001-06-22
K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCorometrics Medical Systems, Inc.1998-12-11
K930714SONICAID MODEL TEAM FECG IUPOxford Instruments, Plc.1995-08-24
K933816SONICAID MODEL P110 FETAL HEAR DETECTOROxford Instruments, Plc.1994-12-22
K780035MINIVISORMetrix Teknika, Inc.1978-03-06

Legacy Summary#

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FDA Review#

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