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FDA 510(k)

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

K-Number: K040525 · 2004-08-17

ApplicantSontra Medical, Inc.
Decision Date2004-08-17
Product CodeNRJ
Advisory CommitteeSU
DecisionUnknown

Device Summary

SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 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 2004-08-17 under 510(k) number K040525. The device is classified under product code NRJ. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000?

SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 is a medical device that received FDA 510(k) clearance on 2004-08-17. The listed applicant is Sontra Medical, Inc.. The 510(k) number is K040525.

When did SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 receive FDA 510(k) clearance?

SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 received FDA 510(k) clearance on 2004-08-17, under 510(k) number K040525.

Who is the listed applicant for SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000?

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

The FDA product code for SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 is NRJ.

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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.

K023713SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000

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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