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FDA 510(k)

DREAM CATCHER

K-Number: K972122 · 1997-08-29

ApplicantRest Technologies, Inc.
Decision Date1997-08-29
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DREAM CATCHER is the device name listed in this FDA 510(k) record. The listed applicant is Rest Technologies, Inc.. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K972122. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DREAM CATCHER?

DREAM CATCHER is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Rest Technologies, Inc.. The 510(k) number is K972122.

When did DREAM CATCHER receive FDA 510(k) clearance?

DREAM CATCHER received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972122.

Who is the listed applicant for DREAM CATCHER?

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

What is the FDA product code for DREAM CATCHER?

The FDA product code for DREAM CATCHER is GXY.

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Official Source

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