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FDA 510(k)

CONTINUOUS VENTILATOR

K-Number: K844809 · 1985-06-27

ApplicantHamilton Medical, Inc.
Decision Date1985-06-27
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONTINUOUS VENTILATOR 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 1985-06-27 under 510(k) number K844809. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUOUS VENTILATOR?

CONTINUOUS VENTILATOR is a medical device that received FDA 510(k) clearance on 1985-06-27. The listed applicant is Hamilton Medical, Inc.. The 510(k) number is K844809.

When did CONTINUOUS VENTILATOR receive FDA 510(k) clearance?

CONTINUOUS VENTILATOR received FDA 510(k) clearance on 1985-06-27, under 510(k) number K844809.

Who is the listed applicant for CONTINUOUS VENTILATOR?

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 CONTINUOUS VENTILATOR?

The FDA product code for CONTINUOUS VENTILATOR is GBX.

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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 MIXERK945740INFANT FLOW SYSTEM

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Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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