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FDA 510(k)

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A

K-Number: K101968 · 2010-09-15

ApplicantSt Jude Medical
Decision Date2010-09-15
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2010-09-15 under 510(k) number K101968. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A?

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A is a medical device that received FDA 510(k) clearance on 2010-09-15. The listed applicant is St Jude Medical. The 510(k) number is K101968.

When did SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A receive FDA 510(k) clearance?

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A received FDA 510(k) clearance on 2010-09-15, under 510(k) number K101968.

Who is the listed applicant for SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A?

The FDA product code for SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A is MXC.

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Related Devices (Code: MXC)

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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