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FDA 510(k)

OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P

K-Number: K092549 · 2009-11-16

ApplicantBio Medical Technologies Co., Ltd.
Decision Date2009-11-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P is the device name listed in this FDA 510(k) record. The listed applicant is Bio Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2009-11-16 under 510(k) number K092549. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P?

OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P is a medical device that received FDA 510(k) clearance on 2009-11-16. The listed applicant is Bio Medical Technologies Co., Ltd.. The 510(k) number is K092549.

When did OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P receive FDA 510(k) clearance?

OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P received FDA 510(k) clearance on 2009-11-16, under 510(k) number K092549.

Who is the listed applicant for OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P?

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

What is the FDA product code for OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P?

The FDA product code for OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P is DQA.

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Related Devices (Code: DQA)

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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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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