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FDA 510(k)

SILENTSLEEP

K-Number: K801927 · 1980-11-14

ApplicantSlumber Research, Inc.
Decision Date1980-11-14
Product CodeDYN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILENTSLEEP is the device name listed in this FDA 510(k) record. The listed applicant is Slumber Research, Inc.. It received FDA 510(k) clearance on 1980-11-14 under 510(k) number K801927. The device is classified under product code DYN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILENTSLEEP?

SILENTSLEEP is a medical device that received FDA 510(k) clearance on 1980-11-14. The listed applicant is Slumber Research, Inc.. The 510(k) number is K801927.

When did SILENTSLEEP receive FDA 510(k) clearance?

SILENTSLEEP received FDA 510(k) clearance on 1980-11-14, under 510(k) number K801927.

Who is the listed applicant for SILENTSLEEP?

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

What is the FDA product code for SILENTSLEEP?

The FDA product code for SILENTSLEEP is DYN.

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Related Devices (Code: DYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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