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FDA 510(k)

SILHOUETTE, MODEL 1000.01

K-Number: K070426 · 2007-06-29

ApplicantAranz Medical Limited
Decision Date2007-06-29
Product CodeFXN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILHOUETTE, MODEL 1000.01 is the device name listed in this FDA 510(k) record. The listed applicant is Aranz Medical Limited. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K070426. The device is classified under product code FXN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILHOUETTE, MODEL 1000.01?

SILHOUETTE, MODEL 1000.01 is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Aranz Medical Limited. The 510(k) number is K070426.

When did SILHOUETTE, MODEL 1000.01 receive FDA 510(k) clearance?

SILHOUETTE, MODEL 1000.01 received FDA 510(k) clearance on 2007-06-29, under 510(k) number K070426.

Who is the listed applicant for SILHOUETTE, MODEL 1000.01?

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

What is the FDA product code for SILHOUETTE, MODEL 1000.01?

The FDA product code for SILHOUETTE, MODEL 1000.01 is FXN.

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Related Devices (Code: FXN)

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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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