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FDA 510(k)

PORTABLE SLEEP DATA RECORDER (PSDR)

K-Number: K033402 · 2004-06-30

ApplicantPro-Tech Services, Inc.
Decision Date2004-06-30
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE SLEEP DATA RECORDER (PSDR) is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Tech Services, Inc.. It received FDA 510(k) clearance on 2004-06-30 under 510(k) number K033402. 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 PORTABLE SLEEP DATA RECORDER (PSDR)?

PORTABLE SLEEP DATA RECORDER (PSDR) is a medical device that received FDA 510(k) clearance on 2004-06-30. The listed applicant is Pro-Tech Services, Inc.. The 510(k) number is K033402.

When did PORTABLE SLEEP DATA RECORDER (PSDR) receive FDA 510(k) clearance?

PORTABLE SLEEP DATA RECORDER (PSDR) received FDA 510(k) clearance on 2004-06-30, under 510(k) number K033402.

Who is the listed applicant for PORTABLE SLEEP DATA RECORDER (PSDR)?

The FDA 510(k) record lists Pro-Tech Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTABLE SLEEP DATA RECORDER (PSDR)?

The FDA product code for PORTABLE SLEEP DATA RECORDER (PSDR) is MNR.

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Other records listing Pro-Tech Services, Inc. as applicant

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Related Devices (Code: MNR)

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K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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