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FDA 510(k)

IDR

K-Number: K082450 · 2009-06-30

ApplicantIcrco, Inc.
Decision Date2009-06-30
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IDR is the device name listed in this FDA 510(k) record. The listed applicant is Icrco, Inc.. It received FDA 510(k) clearance on 2009-06-30 under 510(k) number K082450. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDR?

IDR is a medical device that received FDA 510(k) clearance on 2009-06-30. The listed applicant is Icrco, Inc.. The 510(k) number is K082450.

When did IDR receive FDA 510(k) clearance?

IDR received FDA 510(k) clearance on 2009-06-30, under 510(k) number K082450.

Who is the listed applicant for IDR?

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

What is the FDA product code for IDR?

The FDA product code for IDR is MQB.

Related PubMed Literature

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.

PMID: 35047882Medical Device Sterilization and Reprocessing in the Era of Multidrug-Resistant (MDR) Bacteria: Issues and Regulatory Concepts.Frontiers in medical technology ()PMID: 31423318Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes.BMJ open gastroenterology ()

Other records listing Icrco, 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.

K122510ICRCO 3600MK120753CLARISCTK113449FUSION FLAT PANEL

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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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