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FDA 510(k)

C. NET 2100

K-Number: K010396 · 2001-10-04

ApplicantCardionetics, Ltd.
Decision Date2001-10-04
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

C. NET 2100 is the device name listed in this FDA 510(k) record. The listed applicant is Cardionetics, Ltd.. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K010396. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C. NET 2100?

C. NET 2100 is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Cardionetics, Ltd.. The 510(k) number is K010396.

When did C. NET 2100 receive FDA 510(k) clearance?

C. NET 2100 received FDA 510(k) clearance on 2001-10-04, under 510(k) number K010396.

Who is the listed applicant for C. NET 2100?

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

What is the FDA product code for C. NET 2100?

The FDA product code for C. NET 2100 is MLO.

Related Devices (Code: MLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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