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FDA 510(k)

REFSTAR RMT EXTERNAL REFERENCE PATCH

K-Number: K042998 · 2005-09-29

ApplicantBiosense Webster, Inc.
Decision Date2005-09-29
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REFSTAR RMT EXTERNAL REFERENCE PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2005-09-29 under 510(k) number K042998. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFSTAR RMT EXTERNAL REFERENCE PATCH?

REFSTAR RMT EXTERNAL REFERENCE PATCH is a medical device that received FDA 510(k) clearance on 2005-09-29. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K042998.

When did REFSTAR RMT EXTERNAL REFERENCE PATCH receive FDA 510(k) clearance?

REFSTAR RMT EXTERNAL REFERENCE PATCH received FDA 510(k) clearance on 2005-09-29, under 510(k) number K042998.

Who is the listed applicant for REFSTAR RMT EXTERNAL REFERENCE PATCH?

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

What is the FDA product code for REFSTAR RMT EXTERNAL REFERENCE PATCH?

The FDA product code for REFSTAR RMT EXTERNAL REFERENCE PATCH is DRF.

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Related Devices (Code: DRF)

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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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