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FDA 510(k)

HYPERTHERMIA PUMP

K-Number: K070654 · 2007-06-08

ApplicantBelmont Instrument Corp.
Decision Date2007-06-08
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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 2007-06-08 under 510(k) number K070654. 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 HYPERTHERMIA PUMP?

HYPERTHERMIA PUMP is a medical device that received FDA 510(k) clearance on 2007-06-08. The listed applicant is Belmont Instrument Corp.. The 510(k) number is K070654.

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

HYPERTHERMIA PUMP received FDA 510(k) clearance on 2007-06-08, under 510(k) number K070654.

Who is the listed applicant for 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 HYPERTHERMIA PUMP?

The FDA product code for 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.

K131519BELMONT HYPERTHERMIA PUMPK112639THE BELMONT BUDDY LITE FLUID WARMERK091855THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000K090508THE BELMONT BUDDY LITE FLUID WARMERK090089BELMONT HYPERTHERMIA 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.

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU MedicalK260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

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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