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FDA 510(k)

BELMONT HYPERTHERMIA PUMP

K-Number: K131519 · 2013-11-06

ApplicantBelmont Instrument Corp.
Decision Date2013-11-06
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BELMONT HYPERTHERMIA PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Belmont Instrument Corp.. It received FDA 510(k) clearance on 2013-11-06 under 510(k) number K131519. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELMONT HYPERTHERMIA PUMP?

BELMONT HYPERTHERMIA PUMP is a medical device that received FDA 510(k) clearance on 2013-11-06. The listed applicant is Belmont Instrument Corp.. The 510(k) number is K131519.

When did BELMONT HYPERTHERMIA PUMP receive FDA 510(k) clearance?

BELMONT HYPERTHERMIA PUMP received FDA 510(k) clearance on 2013-11-06, under 510(k) number K131519.

Who is the listed applicant for BELMONT HYPERTHERMIA PUMP?

The FDA 510(k) record lists Belmont Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BELMONT HYPERTHERMIA PUMP?

The FDA product code for BELMONT HYPERTHERMIA PUMP is LGZ.

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Other records listing Belmont Instrument Corp. 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.

K112639THE BELMONT BUDDY LITE FLUID WARMERK091855THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000K090508THE BELMONT BUDDY LITE FLUID WARMERK090089BELMONT HYPERTHERMIA PUMPK070654HYPERTHERMIA PUMPK062774BELMONT BUDDY PLUS FLUID WARMER

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Related Devices (Code: LGZ)

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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