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FDA 510(k)

BCM-400C

K-Number: K920862 · 1992-09-30

ApplicantB C Medical , Ltd.
Decision Date1992-09-30
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BCM-400C is the device name listed in this FDA 510(k) record. The listed applicant is B C Medical , Ltd.. It received FDA 510(k) clearance on 1992-09-30 under 510(k) number K920862. 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 BCM-400C?

BCM-400C is a medical device that received FDA 510(k) clearance on 1992-09-30. The listed applicant is B C Medical , Ltd.. The 510(k) number is K920862.

When did BCM-400C receive FDA 510(k) clearance?

BCM-400C received FDA 510(k) clearance on 1992-09-30, under 510(k) number K920862.

Who is the listed applicant for BCM-400C?

The FDA 510(k) record lists B C Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BCM-400C?

The FDA product code for BCM-400C is IZI.

Other records listing B C Medical , Ltd. 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.

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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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