Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BT-200V VASCULAR DOPPLER

K-Number: K121267 · 2012-08-02

ApplicantBistos Co., Ltd.
Decision Date2012-08-02
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BT-200V VASCULAR DOPPLER is the device name listed in this FDA 510(k) record. The listed applicant is Bistos Co., Ltd.. It received FDA 510(k) clearance on 2012-08-02 under 510(k) number K121267. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BT-200V VASCULAR DOPPLER?

BT-200V VASCULAR DOPPLER is a medical device that received FDA 510(k) clearance on 2012-08-02. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K121267.

When did BT-200V VASCULAR DOPPLER receive FDA 510(k) clearance?

BT-200V VASCULAR DOPPLER received FDA 510(k) clearance on 2012-08-02, under 510(k) number K121267.

Who is the listed applicant for BT-200V VASCULAR DOPPLER?

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

What is the FDA product code for BT-200V VASCULAR DOPPLER?

The FDA product code for BT-200V VASCULAR DOPPLER is HGM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bistos Co., 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.

K251512Hi bebe super (BT-150B)K232991BT-1000K210289Infant Phototherapy EquipmentK200675Hi bebe super (Models BT-150S and BT-150L)K160274Hi bebe plusK103545BT-350

View all 9 devices →

Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

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.

↑