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FDA 510(k)

FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000

K-Number: K993046 · 1999-11-22

ApplicantFibra Sonics, Inc.
Decision Date1999-11-22
Product CodeFEO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Fibra Sonics, Inc.. It received FDA 510(k) clearance on 1999-11-22 under 510(k) number K993046. The device is classified under product code FEO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000?

FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 is a medical device that received FDA 510(k) clearance on 1999-11-22. The listed applicant is Fibra Sonics, Inc.. The 510(k) number is K993046.

When did FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 receive FDA 510(k) clearance?

FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 received FDA 510(k) clearance on 1999-11-22, under 510(k) number K993046.

Who is the listed applicant for FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000?

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

What is the FDA product code for FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000?

The FDA product code for FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 is FEO.

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Other records listing Fibra Sonics, Inc. as applicant

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Related Devices (Code: FEO)

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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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