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FDA 510(k)

SINMED POSITIONING DEVICES

K-Number: K060737 · 2006-03-31

ApplicantSinmed BV
Decision Date2006-03-31
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SINMED POSITIONING DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Sinmed BV. It received FDA 510(k) clearance on 2006-03-31 under 510(k) number K060737. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINMED POSITIONING DEVICES?

SINMED POSITIONING DEVICES is a medical device that received FDA 510(k) clearance on 2006-03-31. The listed applicant is Sinmed BV. The 510(k) number is K060737.

When did SINMED POSITIONING DEVICES receive FDA 510(k) clearance?

SINMED POSITIONING DEVICES received FDA 510(k) clearance on 2006-03-31, under 510(k) number K060737.

Who is the listed applicant for SINMED POSITIONING DEVICES?

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

What is the FDA product code for SINMED POSITIONING DEVICES?

The FDA product code for SINMED POSITIONING DEVICES is IYE.

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Related Devices (Code: IYE)

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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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