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FDA 510(k)

MH1 MICROHOLTER RECORDER

K-Number: K101969 · 2011-02-04

ApplicantExelys, LLC
Decision Date2011-02-04
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MH1 MICROHOLTER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Exelys, LLC. It received FDA 510(k) clearance on 2011-02-04 under 510(k) number K101969. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MH1 MICROHOLTER RECORDER?

MH1 MICROHOLTER RECORDER is a medical device that received FDA 510(k) clearance on 2011-02-04. The listed applicant is Exelys, LLC. The 510(k) number is K101969.

When did MH1 MICROHOLTER RECORDER receive FDA 510(k) clearance?

MH1 MICROHOLTER RECORDER received FDA 510(k) clearance on 2011-02-04, under 510(k) number K101969.

Who is the listed applicant for MH1 MICROHOLTER RECORDER?

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

What is the FDA product code for MH1 MICROHOLTER RECORDER?

The FDA product code for MH1 MICROHOLTER RECORDER is MWJ.

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Related Devices (Code: MWJ)

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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