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510(k) K930253

Device
Cardio2 Ctcke
Applicant
ERGOMETRX, INC.
510(k) number
K930253
Product code
ISD
Decision
Substantially Equivalent (SESE)
Decision date
1993-10-18
Date received
1993-01-19
Regulation
890.5360
Classification name
Exerciser, Measuring
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CONSTANCE G BUNDY
Address
6470 Riverview Ter. Findley MN US 55432 55432

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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