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FDA 510(k)

ETHYLENE OXIDE DETECTOR GLD-1-07

K-Number: K834152 · 1984-03-19

ApplicantCalnor of EL Paseo, Inc.
Decision Date1984-03-19
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ETHYLENE OXIDE DETECTOR GLD-1-07 is the device name listed in this FDA 510(k) record. The listed applicant is Calnor of EL Paseo, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K834152. 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 ETHYLENE OXIDE DETECTOR GLD-1-07?

ETHYLENE OXIDE DETECTOR GLD-1-07 is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Calnor of EL Paseo, Inc.. The 510(k) number is K834152.

When did ETHYLENE OXIDE DETECTOR GLD-1-07 receive FDA 510(k) clearance?

ETHYLENE OXIDE DETECTOR GLD-1-07 received FDA 510(k) clearance on 1984-03-19, under 510(k) number K834152.

Who is the listed applicant for ETHYLENE OXIDE DETECTOR GLD-1-07?

The FDA 510(k) record lists Calnor of EL Paseo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHYLENE OXIDE DETECTOR GLD-1-07?

The FDA product code for ETHYLENE OXIDE DETECTOR GLD-1-07 is FLE.

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Other records listing Calnor of EL Paseo, Inc. 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.

K842288EEG 130K842353TEMPERATURE 132K842354EMG MODEL 133K841895GSR, 126, EEG 130-TEMP. 132, EMG 133K771577CLINICAL EMG MODEL 133

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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