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FDA 510(k)

SURFACE BEACON TRANSPONDERS

K-Number: K112841 · 2012-02-16

ApplicantCalypso Medical Technologies, Inc.
Decision Date2012-02-16
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURFACE BEACON TRANSPONDERS is the device name listed in this FDA 510(k) record. The listed applicant is Calypso Medical Technologies, Inc.. It received FDA 510(k) clearance on 2012-02-16 under 510(k) number K112841. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURFACE BEACON TRANSPONDERS?

SURFACE BEACON TRANSPONDERS is a medical device that received FDA 510(k) clearance on 2012-02-16. The listed applicant is Calypso Medical Technologies, Inc.. The 510(k) number is K112841.

When did SURFACE BEACON TRANSPONDERS receive FDA 510(k) clearance?

SURFACE BEACON TRANSPONDERS received FDA 510(k) clearance on 2012-02-16, under 510(k) number K112841.

Who is the listed applicant for SURFACE BEACON TRANSPONDERS?

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

What is the FDA product code for SURFACE BEACON TRANSPONDERS?

The FDA product code for SURFACE BEACON TRANSPONDERS is IYE.

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Other records listing Calypso Medical Technologies, Inc. as applicant

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

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

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