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FDA 510(k)

PASR/QUIETNITE

K-Number: K093340 · 2010-06-11

ApplicantExact Supplies , Ltd.
Decision Date2010-06-11
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PASR/QUIETNITE is the device name listed in this FDA 510(k) record. The listed applicant is Exact Supplies , Ltd.. It received FDA 510(k) clearance on 2010-06-11 under 510(k) number K093340. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASR/QUIETNITE?

PASR/QUIETNITE is a medical device that received FDA 510(k) clearance on 2010-06-11. The listed applicant is Exact Supplies , Ltd.. The 510(k) number is K093340.

When did PASR/QUIETNITE receive FDA 510(k) clearance?

PASR/QUIETNITE received FDA 510(k) clearance on 2010-06-11, under 510(k) number K093340.

Who is the listed applicant for PASR/QUIETNITE?

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

What is the FDA product code for PASR/QUIETNITE?

The FDA product code for PASR/QUIETNITE is LRK.

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Related Devices (Code: LRK)

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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