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FDA 510(k)

H12+ HOLTER RECORDER

K-Number: K050896 · 2005-08-24

ApplicantMortara Instrument, Inc.
Decision Date2005-08-24
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

H12+ HOLTER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2005-08-24 under 510(k) number K050896. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H12+ HOLTER RECORDER?

H12+ HOLTER RECORDER is a medical device that received FDA 510(k) clearance on 2005-08-24. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K050896.

When did H12+ HOLTER RECORDER receive FDA 510(k) clearance?

H12+ HOLTER RECORDER received FDA 510(k) clearance on 2005-08-24, under 510(k) number K050896.

Who is the listed applicant for H12+ HOLTER RECORDER?

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

What is the FDA product code for H12+ HOLTER RECORDER?

The FDA product code for H12+ HOLTER RECORDER is DSH.

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Related Devices (Code: DSH)

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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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