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FDA 510(k)

THERACAL LC

K-Number: K063237 · 2006-12-08

ApplicantBisco, Inc.
Decision Date2006-12-08
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THERACAL LC is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2006-12-08 under 510(k) number K063237. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERACAL LC?

THERACAL LC is a medical device that received FDA 510(k) clearance on 2006-12-08. The listed applicant is Bisco, Inc.. The 510(k) number is K063237.

When did THERACAL LC receive FDA 510(k) clearance?

THERACAL LC received FDA 510(k) clearance on 2006-12-08, under 510(k) number K063237.

Who is the listed applicant for THERACAL LC?

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

What is the FDA product code for THERACAL LC?

The FDA product code for THERACAL LC is EJK.

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Other records listing Bisco, 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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Related Devices (Code: EJK)

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

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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