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FDA 510(k)

INFANT FLOW SYSTEM

K-Number: K945740 · 1995-03-23

ApplicantHamilton Medical, Inc.
Decision Date1995-03-23
Product CodeBZO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT FLOW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical, Inc.. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K945740. The device is classified under product code BZO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT FLOW SYSTEM?

INFANT FLOW SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Hamilton Medical, Inc.. The 510(k) number is K945740.

When did INFANT FLOW SYSTEM receive FDA 510(k) clearance?

INFANT FLOW SYSTEM received FDA 510(k) clearance on 1995-03-23, under 510(k) number K945740.

Who is the listed applicant for INFANT FLOW SYSTEM?

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

What is the FDA product code for INFANT FLOW SYSTEM?

The FDA product code for INFANT FLOW SYSTEM is BZO.

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Other records listing Hamilton Medical, 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.

K040574GALILEO GOLDK001686GALILEO VENTILATORK982910HAMILTON MEDICAL GALILEOVENTILATORK990293ALADDIN II MONITORING OXYGEN/AIR MONITORK960359ALADDIN MONITORING OXYGEN/AIR MIXERK901448VEOLAR VENTILATOR

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Related Devices (Code: BZO)

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.

K953784UNICOR, INC. CORRUGATED TUBINGUnicor, Inc.K953785UNICOR, INC. VENTILATOR HOSESUnicor, Inc.K952011PRIMA BREATHING BAGSPrima, Inc.K952022PRIMA VOLUMN VENTILATORSSPrima, Inc.K952010PRIMA VENTILATOR HOSESPrima, Inc.K952012PRIMA CUSTOM ANESTESIA CIRCUITPrima, Inc.

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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