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FDA 510(k)

HI FLOW 50

K-Number: K882328 · 1988-06-28

ApplicantMinnesota Valley Engineering, Inc.
Decision Date1988-06-28
Product CodeBYJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HI FLOW 50 is the device name listed in this FDA 510(k) record. The listed applicant is Minnesota Valley Engineering, Inc.. It received FDA 510(k) clearance on 1988-06-28 under 510(k) number K882328. The device is classified under product code BYJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI FLOW 50?

HI FLOW 50 is a medical device that received FDA 510(k) clearance on 1988-06-28. The listed applicant is Minnesota Valley Engineering, Inc.. The 510(k) number is K882328.

When did HI FLOW 50 receive FDA 510(k) clearance?

HI FLOW 50 received FDA 510(k) clearance on 1988-06-28, under 510(k) number K882328.

Who is the listed applicant for HI FLOW 50?

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

What is the FDA product code for HI FLOW 50?

The FDA product code for HI FLOW 50 is BYJ.

Other records listing Minnesota Valley Engineering, 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.

K875352HI FLOW PORTABLE LIQUID OXYGEN UNITK880101LIBERATOR 53/STROLLER 50K872449NOMAD (BASE UNIT/PORTABLE UNIT)

Related Devices (Code: BYJ)

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.

K130068DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)Essex Industries, Inc. D/B/A Essex Cryogenics of MK113767MOUNTED MEDICAL OXYGEN SYSTEMEssex Industries, Inc.K103324PRECISION LIQUID OXYGEN SYSTEMPrecision Medical, Inc.K101272MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3Essex Industries, Inc.K081779GOLOX-93Respironics, Inc.K080023MODIFICATION TO: SPIRITCaire, 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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