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FDA 510(k)

BIOTHERM

K-Number: K833839 · 1983-12-27

ApplicantTrileen, Inc.
Decision Date1983-12-27
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOTHERM is the device name listed in this FDA 510(k) record. The listed applicant is Trileen, Inc.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833839. The device is classified under product code ILJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTHERM?

BIOTHERM is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Trileen, Inc.. The 510(k) number is K833839.

When did BIOTHERM receive FDA 510(k) clearance?

BIOTHERM received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833839.

Who is the listed applicant for BIOTHERM?

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

What is the FDA product code for BIOTHERM?

The FDA product code for BIOTHERM is ILJ.

Related Clinical Trials

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Other records listing Trileen, 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.

K833840MASSATOR-PEDIO

Related Devices (Code: ILJ)

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.

K110994PARKER 500Arjohuntleigh, Inc.K082951IMMERSION HYDROBATHArjo Hospital Equipment ABK052479MBATH 1000 (60)Enneking Medical, Inc.K040772PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEMPenner Manufacturing, Inc.K012061SUPERIOR BATH, MODEL 6300Penner Manufacturing, Inc.K012057CASCADE BATH, MODEL 6900Penner Manufacturing, Inc.

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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