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FDA 510(k)

REST X SYSTEM

K-Number: K970428 · 1997-05-14

ApplicantRestxsys
Decision Date1997-05-14
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REST X SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Restxsys. It received FDA 510(k) clearance on 1997-05-14 under 510(k) number K970428. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REST X SYSTEM?

REST X SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-14. The listed applicant is Restxsys. The 510(k) number is K970428.

When did REST X SYSTEM receive FDA 510(k) clearance?

REST X SYSTEM received FDA 510(k) clearance on 1997-05-14, under 510(k) number K970428.

Who is the listed applicant for REST X SYSTEM?

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

What is the FDA product code for REST X SYSTEM?

The FDA product code for REST X SYSTEM is FNM.

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Related Devices (Code: FNM)

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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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