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FDA 510(k)

LUMISCOPE MODEL 1000/APCC MODEL 1000

K-Number: K894127 · 1989-09-06

ApplicantLumiscope Co., Inc.
Decision Date1989-09-06
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LUMISCOPE MODEL 1000/APCC MODEL 1000 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 1989-09-06 under 510(k) number K894127. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMISCOPE MODEL 1000/APCC MODEL 1000?

LUMISCOPE MODEL 1000/APCC MODEL 1000 is a medical device that received FDA 510(k) clearance on 1989-09-06. The listed applicant is Lumiscope Co., Inc.. The 510(k) number is K894127.

When did LUMISCOPE MODEL 1000/APCC MODEL 1000 receive FDA 510(k) clearance?

LUMISCOPE MODEL 1000/APCC MODEL 1000 received FDA 510(k) clearance on 1989-09-06, under 510(k) number K894127.

Who is the listed applicant for LUMISCOPE MODEL 1000/APCC MODEL 1000?

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 MODEL 1000/APCC MODEL 1000?

The FDA product code for LUMISCOPE MODEL 1000/APCC MODEL 1000 is GZJ.

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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: GZJ)

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

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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