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FDA 510(k)

DYNEMO 3000

K-Number: K972798 · 1998-02-24

ApplicantSometec, Inc.
Decision Date1998-02-24
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DYNEMO 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Sometec, Inc.. It received FDA 510(k) clearance on 1998-02-24 under 510(k) number K972798. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNEMO 3000?

DYNEMO 3000 is a medical device that received FDA 510(k) clearance on 1998-02-24. The listed applicant is Sometec, Inc.. The 510(k) number is K972798.

When did DYNEMO 3000 receive FDA 510(k) clearance?

DYNEMO 3000 received FDA 510(k) clearance on 1998-02-24, under 510(k) number K972798.

Who is the listed applicant for DYNEMO 3000?

The FDA 510(k) record lists Sometec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNEMO 3000?

The FDA product code for DYNEMO 3000 is DPW.

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Official Source

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