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FDA 510(k)

TEMP 3

K-Number: K012276 · 2001-08-20

ApplicantMedical Solutions, Inc.
Decision Date2001-08-20
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMP 3 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 2001-08-20 under 510(k) number K012276. 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 TEMP 3?

TEMP 3 is a medical device that received FDA 510(k) clearance on 2001-08-20. The listed applicant is Medical Solutions, Inc.. The 510(k) number is K012276.

When did TEMP 3 receive FDA 510(k) clearance?

TEMP 3 received FDA 510(k) clearance on 2001-08-20, under 510(k) number K012276.

Who is the listed applicant for TEMP 3?

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 TEMP 3?

The FDA product code for TEMP 3 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.

K0418398NONEK981032PIV 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

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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