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FDA 510(k)

ANIMEC, MODELS AM-2S-4 AND AM-2S-5

K-Number: K012906 · 2001-10-09

ApplicantElltec Co., Ltd.
Decision Date2001-10-09
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ANIMEC, MODELS AM-2S-4 AND AM-2S-5 is the device name listed in this FDA 510(k) record. The listed applicant is Elltec Co., Ltd.. It received FDA 510(k) clearance on 2001-10-09 under 510(k) number K012906. 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 ANIMEC, MODELS AM-2S-4 AND AM-2S-5?

ANIMEC, MODELS AM-2S-4 AND AM-2S-5 is a medical device that received FDA 510(k) clearance on 2001-10-09. The listed applicant is Elltec Co., Ltd.. The 510(k) number is K012906.

When did ANIMEC, MODELS AM-2S-4 AND AM-2S-5 receive FDA 510(k) clearance?

ANIMEC, MODELS AM-2S-4 AND AM-2S-5 received FDA 510(k) clearance on 2001-10-09, under 510(k) number K012906.

Who is the listed applicant for ANIMEC, MODELS AM-2S-4 AND AM-2S-5?

The FDA 510(k) record lists Elltec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANIMEC, MODELS AM-2S-4 AND AM-2S-5?

The FDA product code for ANIMEC, MODELS AM-2S-4 AND AM-2S-5 is LGZ.

Related Clinical Trials

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.

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Other records listing Elltec Co., Ltd. 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.

K024373MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

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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