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FDA 510(k)

XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40

K-Number: K991900 · 1999-07-12

ApplicantExcel Tech. , Ltd.
Decision Date1999-07-12
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 is the device name listed in this FDA 510(k) record. The listed applicant is Excel Tech. , Ltd.. It received FDA 510(k) clearance on 1999-07-12 under 510(k) number K991900. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40?

XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 is a medical device that received FDA 510(k) clearance on 1999-07-12. The listed applicant is Excel Tech. , Ltd.. The 510(k) number is K991900.

When did XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 receive FDA 510(k) clearance?

XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 received FDA 510(k) clearance on 1999-07-12, under 510(k) number K991900.

Who is the listed applicant for XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40?

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

What is the FDA product code for XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40?

The FDA product code for XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 is OLV.

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Other records listing Excel Tech. , Ltd. as applicant

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.

K062549XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238K061269XLTEK CLEAN SIGNAL ADHESIVE ELECTRODESK053386XLTEK EMU40 EEG HEADBOX, MODEL PK1072K053058XLTEK NEUROPATH, MODEL PK1070K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059K052111XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382

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Related Devices (Code: OLV)

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.

K261747Report StudioBeacon Biosignals, Inc.K260585Noxturnal WebNox Medical EhfK242447Falcon HSTCompumedics LimitedK241288Noxturnal WebNox Medical EhfK240700HomeSleepTest (HST, HST REM+)Somnomedics GmbHK213007Cerebra Sleep SystemCerebra Medical , Ltd.

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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