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FDA 510(k)

PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V

K-Number: K032192 · 2004-08-12

ApplicantTuttnauer U.S.A Co, Ltd.
Decision Date2004-08-12
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V 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 2004-08-12 under 510(k) number K032192. 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 PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V?

PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Tuttnauer U.S.A Co, Ltd.. The 510(k) number is K032192.

When did PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V receive FDA 510(k) clearance?

PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V received FDA 510(k) clearance on 2004-08-12, under 510(k) number K032192.

Who is the listed applicant for PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V?

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 PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V?

The FDA product code for PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V is FLE.

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Other records listing Tuttnauer U.S.A Co, Ltd. as applicant

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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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