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)

ECHOHEART TRANSVAGINAL DOPPLER PROBE

K-Number: K060410 · 2006-04-10

ApplicantSummit Doppler Systems, Inc.
Decision Date2006-04-10
Product CodeHEK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ECHOHEART TRANSVAGINAL DOPPLER PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Summit Doppler Systems, Inc.. It received FDA 510(k) clearance on 2006-04-10 under 510(k) number K060410. The device is classified under product code HEK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOHEART TRANSVAGINAL DOPPLER PROBE?

ECHOHEART TRANSVAGINAL DOPPLER PROBE is a medical device that received FDA 510(k) clearance on 2006-04-10. The listed applicant is Summit Doppler Systems, Inc.. The 510(k) number is K060410.

When did ECHOHEART TRANSVAGINAL DOPPLER PROBE receive FDA 510(k) clearance?

ECHOHEART TRANSVAGINAL DOPPLER PROBE received FDA 510(k) clearance on 2006-04-10, under 510(k) number K060410.

Who is the listed applicant for ECHOHEART TRANSVAGINAL DOPPLER PROBE?

The FDA 510(k) record lists Summit Doppler Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHOHEART TRANSVAGINAL DOPPLER PROBE?

The FDA product code for ECHOHEART TRANSVAGINAL DOPPLER PROBE is HEK.

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 Summit Doppler Systems, Inc. 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.

K103693VANTAGE ABIK101816STN PROBEK093393LIFEDOP MODEL 300ABIK090499LIFEDOP MODEL, L350RK063600VISTA AVSK024197LIFEDOP DOPPLER

View all 7 devices →

Related Devices (Code: HEK)

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.

K902190FETAL PULSE DETECTOR MODEL DOP-1Advanced Medical Systems, Inc.K883334BIODOP(TM)Diagnosis Related Systems, Inc.K771211DOPPLER (UTD-5 & UTD-6)Terumo America, 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.

↑