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

K092549 Class II Traditional
Decision Date
2009-11-16
Sponsor / Applicant
Bio Medical Technologies Co., Ltd.

Technical Specification

510(k) Submission ID K092549
Product Code DQA
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.2700
Decision Date 2009-11-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P received FDA 510(k) clearance under submission number K092549, sponsored by Bio Medical Technologies Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-11-16.

Classification & Regulation

This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.