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FDA 510(k)

STAT IM 5000 CASSETTE AUTOCLAVE

K-Number: K962179 · 1997-01-13

ApplicantScican
Decision Date1997-01-13
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STAT IM 5000 CASSETTE AUTOCLAVE is the device name listed in this FDA 510(k) record. The listed applicant is Scican. It received FDA 510(k) clearance on 1997-01-13 under 510(k) number K962179. 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 STAT IM 5000 CASSETTE AUTOCLAVE?

STAT IM 5000 CASSETTE AUTOCLAVE is a medical device that received FDA 510(k) clearance on 1997-01-13. The listed applicant is Scican. The 510(k) number is K962179.

When did STAT IM 5000 CASSETTE AUTOCLAVE receive FDA 510(k) clearance?

STAT IM 5000 CASSETTE AUTOCLAVE received FDA 510(k) clearance on 1997-01-13, under 510(k) number K962179.

Who is the listed applicant for STAT IM 5000 CASSETTE AUTOCLAVE?

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

What is the FDA product code for STAT IM 5000 CASSETTE AUTOCLAVE?

The FDA product code for STAT IM 5000 CASSETTE AUTOCLAVE is FLE.

Related Clinical Trials

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Other records listing Scican 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.

K062418K-SPRAY, MODEL 085-2715K021064QUANTIM 16 AUTOCLAVEK983679STATIM 5000 CASSETTE AUTOCLAVEK964691TCB TEMPORARY CROWN AND BRIDGE MATERIALK944036STERIMASTER AUTOCLAVEK945142POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)

View all 9 devices →

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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