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FDA 510(k)

BCM 400CP

K-Number: K946378 · 1995-05-04

ApplicantB C Medical , Ltd.
Decision Date1995-05-04
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BCM 400CP 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 1995-05-04 under 510(k) number K946378. 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 400CP?

BCM 400CP is a medical device that received FDA 510(k) clearance on 1995-05-04. The listed applicant is B C Medical , Ltd.. The 510(k) number is K946378.

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

BCM 400CP received FDA 510(k) clearance on 1995-05-04, under 510(k) number K946378.

Who is the listed applicant for BCM 400CP?

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 400CP?

The FDA product code for BCM 400CP 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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