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FDA 510(k)

FLUID MANAGEMENT SYSTEM

K-Number: K972284 · 1997-11-13

ApplicantBelmont Instrument Corp.
Decision Date1997-11-13
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

FLUID MANAGEMENT SYSTEM 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 1997-11-13 under 510(k) number K972284. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the FLUID MANAGEMENT SYSTEM?

FLUID MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Belmont Instrument Corp.. The 510(k) number is K972284.

When did FLUID MANAGEMENT SYSTEM receive FDA 510(k) clearance?

FLUID MANAGEMENT SYSTEM received FDA 510(k) clearance on 1997-11-13, under 510(k) number K972284.

Who is the listed applicant for FLUID MANAGEMENT SYSTEM?

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 FLUID MANAGEMENT SYSTEM?

The FDA product code for FLUID MANAGEMENT SYSTEM is FRN.

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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 PUMPK070654HYPERTHERMIA PUMP

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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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