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FDA 510(k)

ROTAX-II BI-PLANE CIRCULAR ARM

K-Number: K870205 · 1987-03-06

ApplicantB C Medical , Ltd.
Decision Date1987-03-06
Product Code
DecisionSubstantially Equivalent

Device Summary

ROTAX-II BI-PLANE CIRCULAR ARM 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 1987-03-06 under 510(k) number K870205. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTAX-II BI-PLANE CIRCULAR ARM?

ROTAX-II BI-PLANE CIRCULAR ARM is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is B C Medical , Ltd.. The 510(k) number is K870205.

When did ROTAX-II BI-PLANE CIRCULAR ARM receive FDA 510(k) clearance?

ROTAX-II BI-PLANE CIRCULAR ARM received FDA 510(k) clearance on 1987-03-06, under 510(k) number K870205.

Who is the listed applicant for ROTAX-II BI-PLANE CIRCULAR ARM?

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

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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.

K946378BCM 400CPK933100ARC-600K933035BCM-600TXK920862BCM-400CK890306BCM-ARC 105 X-RAY MOBILE UNITK801950BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO

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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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