FDA 510(k)

OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010

K-Number: K000512 · 2000-09-26

Decision Date2000-09-26

Product CodeDXQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 is the device name listed in this FDA 510(k) record. The listed applicant is Cas Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-09-26 under 510(k) number K000512. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010?

OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Cas Medical Systems, Inc.. The 510(k) number is K000512.

When did OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 receive FDA 510(k) clearance?

OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 received FDA 510(k) clearance on 2000-09-26, under 510(k) number K000512.

Who is the listed applicant for OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010?

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

What is the FDA product code for OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010?

The FDA product code for OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 is DXQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.