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FDA 510(k)

FINN CHAMBER (R)

K-Number: K013820 · 2002-01-30

ApplicantEpitest Ltd. OY
Decision Date2002-01-30
Product CodeKXF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FINN CHAMBER (R) is the device name listed in this FDA 510(k) record. The listed applicant is Epitest Ltd. OY. It received FDA 510(k) clearance on 2002-01-30 under 510(k) number K013820. The device is classified under product code KXF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINN CHAMBER (R)?

FINN CHAMBER (R) is a medical device that received FDA 510(k) clearance on 2002-01-30. The listed applicant is Epitest Ltd. OY. The 510(k) number is K013820.

When did FINN CHAMBER (R) receive FDA 510(k) clearance?

FINN CHAMBER (R) received FDA 510(k) clearance on 2002-01-30, under 510(k) number K013820.

Who is the listed applicant for FINN CHAMBER (R)?

The FDA 510(k) record lists Epitest Ltd. OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FINN CHAMBER (R)?

The FDA product code for FINN CHAMBER (R) is KXF.

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Related Devices (Code: KXF)

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.

K123184FINN CHAMBERS AQUASmartpracticeK103409ALLERGEAZE R CLEARSmartpracticeK063160ALLERGEAZE PATCH TEST CHAMBERSSmartpracticeK992553IQ CHAMBERSDormer Laboratories, Inc.K870762EAR APPLICATOR, CATALOG NO. 2229Treace Medical, Inc.K843720COTTON TIPPED APPLICATORS, SINGLEAbco Dealers, Inc.

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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