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FDA 510(k)

SILENT NIGHT I

K-Number: K963597 · 1997-01-23

ApplicantLocal Silence, Inc.
Decision Date1997-01-23
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SILENT NIGHT I is the device name listed in this FDA 510(k) record. The listed applicant is Local Silence, Inc.. It received FDA 510(k) clearance on 1997-01-23 under 510(k) number K963597. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILENT NIGHT I?

SILENT NIGHT I is a medical device that received FDA 510(k) clearance on 1997-01-23. The listed applicant is Local Silence, Inc.. The 510(k) number is K963597.

When did SILENT NIGHT I receive FDA 510(k) clearance?

SILENT NIGHT I received FDA 510(k) clearance on 1997-01-23, under 510(k) number K963597.

Who is the listed applicant for SILENT NIGHT I?

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

What is the FDA product code for SILENT NIGHT I?

The FDA product code for SILENT NIGHT I is MNR.

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Related Devices (Code: MNR)

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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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