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FDA 510(k)

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000

K-Number: K023713 · 2004-01-28

ApplicantSontra Medical, Inc.
Decision Date2004-01-28
Product CodeKRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 is the device name listed in this FDA 510(k) record. The listed applicant is Sontra Medical, Inc.. It received FDA 510(k) clearance on 2004-01-28 under 510(k) number K023713. The device is classified under product code KRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000?

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 is a medical device that received FDA 510(k) clearance on 2004-01-28. The listed applicant is Sontra Medical, Inc.. The 510(k) number is K023713.

When did SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 receive FDA 510(k) clearance?

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 received FDA 510(k) clearance on 2004-01-28, under 510(k) number K023713.

Who is the listed applicant for SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000?

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

What is the FDA product code for SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000?

The FDA product code for SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 is KRC.

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.

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Other records listing Sontra Medical, 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.

K040525SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000

Related Devices (Code: KRC)

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.

K872370BIOMA 3500E.B.S., Inc.K874327SKIN PREP ANALYZERMarquette Electronics, Inc.K874155CIRCAMED MONITOR REMOTE START CONDUCTANCE METERCircadian, Inc.K840358IMPEDANCE/8200 MONITOR-MODEL 8300Aequitron Medical, Inc.K833619CONDUCTANCE METERCircadian, Inc.K830823Z VIEW METER MODEL 300Lintronics Industries, 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.

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