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FDA 510(k)

8NONE

K-Number: K041839 · 2005-02-15

ApplicantMedical Solutions, Inc.
Decision Date2005-02-15
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

8NONE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Solutions, Inc.. It received FDA 510(k) clearance on 2005-02-15 under 510(k) number K041839. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8NONE?

8NONE is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Medical Solutions, Inc.. The 510(k) number is K041839.

When did 8NONE receive FDA 510(k) clearance?

8NONE received FDA 510(k) clearance on 2005-02-15, under 510(k) number K041839.

Who is the listed applicant for 8NONE?

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

What is the FDA product code for 8NONE?

The FDA product code for 8NONE is LGZ.

Other records listing Medical Solutions, 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.

K012276TEMP 3K981032PIV SYSTEMK980086HEAT STACK

Related Devices (Code: LGZ)

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.

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU MedicalK260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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