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FDA 510(k)

ASTOFLO PLUS

K-Number: K082765 · 2008-12-18

ApplicantStihler Electronic GmbH
Decision Date2008-12-18
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASTOFLO PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Stihler Electronic GmbH. It received FDA 510(k) clearance on 2008-12-18 under 510(k) number K082765. 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 ASTOFLO PLUS?

ASTOFLO PLUS is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is Stihler Electronic GmbH. The 510(k) number is K082765.

When did ASTOFLO PLUS receive FDA 510(k) clearance?

ASTOFLO PLUS received FDA 510(k) clearance on 2008-12-18, under 510(k) number K082765.

Who is the listed applicant for ASTOFLO PLUS?

The FDA 510(k) record lists Stihler Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTOFLO PLUS?

The FDA product code for ASTOFLO PLUS is LGZ.

Related Clinical Trials

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Other records listing Stihler Electronic GmbH 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.

K260278ThermAffyx(TM) Patient Safety SystemK202197Astopad Patient Warming SystemK082758PRISMAFLO IIK020103PRISMAFLOK991159PRISMATHERM II, ASTOLINEK991160ASTOTHERM PLUS, ASTOTUBES, ASTOLINE

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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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