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FDA 510(k)

CRC 15ULTRA

K-Number: K052595 · 2005-11-08

ApplicantCapintec, Inc.
Decision Date2005-11-08
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CRC 15ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 2005-11-08 under 510(k) number K052595. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRC 15ULTRA?

CRC 15ULTRA is a medical device that received FDA 510(k) clearance on 2005-11-08. The listed applicant is Capintec, Inc.. The 510(k) number is K052595.

When did CRC 15ULTRA receive FDA 510(k) clearance?

CRC 15ULTRA received FDA 510(k) clearance on 2005-11-08, under 510(k) number K052595.

Who is the listed applicant for CRC 15ULTRA?

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

What is the FDA product code for CRC 15ULTRA?

The FDA product code for CRC 15ULTRA is JAQ.

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Other records listing Capintec, Inc. as applicant

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Related Devices (Code: JAQ)

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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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