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FDA 510(k)

DOWNS ADJUSTABLE FLOW GENERATOR

K-Number: K831503 · 1983-09-12

ApplicantVital Signs, Inc.
Decision Date1983-09-12
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DOWNS ADJUSTABLE FLOW GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K831503. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOWNS ADJUSTABLE FLOW GENERATOR?

DOWNS ADJUSTABLE FLOW GENERATOR is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Vital Signs, Inc.. The 510(k) number is K831503.

When did DOWNS ADJUSTABLE FLOW GENERATOR receive FDA 510(k) clearance?

DOWNS ADJUSTABLE FLOW GENERATOR received FDA 510(k) clearance on 1983-09-12, under 510(k) number K831503.

Who is the listed applicant for DOWNS ADJUSTABLE FLOW GENERATOR?

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

What is the FDA product code for DOWNS ADJUSTABLE FLOW GENERATOR?

The FDA product code for DOWNS ADJUSTABLE FLOW GENERATOR is BYE.

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Other records listing Vital Signs, Inc. as applicant

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Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K112546O_TWO CPAP SYSTEMO-Two Medical Technologies, Inc.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KG

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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