Grindcare Measure

FDA 510(k) K113677 · Medotech A/S

Substantially Equivalent

510(k) numberK113677

Submission

Device name
Grindcare Measure
Applicant
Medotech A/S
Westminster, CO, US
Received
December 14, 2011
Decision date
April 5, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KZM – Device, Muscle Monitoring
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1375
Specialty
Physical Medicine

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Questions and answers

When was Grindcare Measure cleared by the FDA?

Grindcare Measure (K113677) received a 510(k) decision of Substantially Equivalent on April 5, 2012, 113 days after the submission was received.

What is the product code of K113677?

The FDA product code is KZM – Device, Muscle Monitoring, a Class II (moderate risk) device regulated under 21 CFR 890.1375.