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FDA 510(k)

BI-N

K-Number: K924828 · 1992-12-17

ApplicantXre Corp.
Decision Date1992-12-17
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BI-N is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1992-12-17 under 510(k) number K924828. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-N?

BI-N is a medical device that received FDA 510(k) clearance on 1992-12-17. The listed applicant is Xre Corp.. The 510(k) number is K924828.

When did BI-N receive FDA 510(k) clearance?

BI-N received FDA 510(k) clearance on 1992-12-17, under 510(k) number K924828.

Who is the listed applicant for BI-N?

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

What is the FDA product code for BI-N?

The FDA product code for BI-N is IZI.

Other records listing Xre Corp. 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.

K973744UNICATH SP BI-PLANE (MODEL M269 & M289)K961193FULL FRAME ZOOM SYSTEMK960998XRE COLLIMATORK945449UNICATH LLU ANGIOGRAPHIC SYSTEMK936002CINEMAC QASK933460DVFX, MODEL M256

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Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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