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FDA 510(k)

LUMISCOPE EMS 8000

K-Number: K901849 · 1990-08-24

ApplicantLumiscope Co., Inc.
Decision Date1990-08-24
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LUMISCOPE EMS 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Lumiscope Co., Inc.. It received FDA 510(k) clearance on 1990-08-24 under 510(k) number K901849. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMISCOPE EMS 8000?

LUMISCOPE EMS 8000 is a medical device that received FDA 510(k) clearance on 1990-08-24. The listed applicant is Lumiscope Co., Inc.. The 510(k) number is K901849.

When did LUMISCOPE EMS 8000 receive FDA 510(k) clearance?

LUMISCOPE EMS 8000 received FDA 510(k) clearance on 1990-08-24, under 510(k) number K901849.

Who is the listed applicant for LUMISCOPE EMS 8000?

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

What is the FDA product code for LUMISCOPE EMS 8000?

The FDA product code for LUMISCOPE EMS 8000 is IPF.

Related Clinical Trials

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Other records listing Lumiscope Co., Inc. 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.

K032714CARDICARE MODEL MT-301F & MT-301CK954792LUMISCOPE MODEL 2018 THERMOMETERK931768INTERFERENTIAL CURRENT THERAPY UNITK925054INFRARED LAMPK924081LUMISONICK920099GYMMAN

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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