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FDA 510(k)

GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM

K-Number: K021807 · 2002-08-29

ApplicantGrass Instrument Co.
Decision Date2002-08-29
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Grass Instrument Co.. It received FDA 510(k) clearance on 2002-08-29 under 510(k) number K021807. 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 GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM?

GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM is a medical device that received FDA 510(k) clearance on 2002-08-29. The listed applicant is Grass Instrument Co.. The 510(k) number is K021807.

When did GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM receive FDA 510(k) clearance?

GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM received FDA 510(k) clearance on 2002-08-29, under 510(k) number K021807.

Who is the listed applicant for GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM?

The FDA 510(k) record lists Grass Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM?

The FDA product code for GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM is OLV.

Related Clinical Trials

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Other records listing Grass Instrument Co. 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.

K994142GRASS TS3201/6401 EEG AMPLIFIER SYSTEMK844216GRASS MODEL NL FACIAL NERVE LOCATOR & MONITORK812061MODEL S10VS VISUAL STIMULATORK810539MODEL S10CTCM AUDITORY STIMULATORK771742EVOKED RESPONSE SYS., MODEL 10

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

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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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