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FDA 510(k)

TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE

K-Number: K090783 · 2009-08-20

ApplicantTuttnauer U.S.A Co, Ltd.
Decision Date2009-08-20
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer U.S.A Co, Ltd.. It received FDA 510(k) clearance on 2009-08-20 under 510(k) number K090783. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE?

TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE is a medical device that received FDA 510(k) clearance on 2009-08-20. The listed applicant is Tuttnauer U.S.A Co, Ltd.. The 510(k) number is K090783.

When did TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE receive FDA 510(k) clearance?

TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE received FDA 510(k) clearance on 2009-08-20, under 510(k) number K090783.

Who is the listed applicant for TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE?

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

What is the FDA product code for TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE?

The FDA product code for TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE is FLE.

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Other records listing Tuttnauer U.S.A 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.

K232658T-Top 10 & T-Top T-Top 11K032192PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1VK021504TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540K993856TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EPK990761TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTEK962282TUTTNAUER PREVACUUM TABLE AUTOCLAVE

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Related Devices (Code: FLE)

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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

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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