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FDA 510(k)

MODEL 200

K-Number: K830468 · 1983-04-12

ApplicantWestern Laboratories Corp.
Decision Date1983-04-12
Product CodeFTZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 200 is the device name listed in this FDA 510(k) record. The listed applicant is Western Laboratories Corp.. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830468. The device is classified under product code FTZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 200?

MODEL 200 is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is Western Laboratories Corp.. The 510(k) number is K830468.

When did MODEL 200 receive FDA 510(k) clearance?

MODEL 200 received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830468.

Who is the listed applicant for MODEL 200?

The FDA 510(k) record lists Western Laboratories Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 200?

The FDA product code for MODEL 200 is FTZ.

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Other records listing Western Laboratories Corp. 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.

K834024HEPARINOMETERK821834MODEL 100 BICARBONATE CONDUCTIVITYK821415MODEL 90 BCK821414MODEL 80 BCK801303MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TESTK780932MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT

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Related Devices (Code: FTZ)

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.

K833229SUN BED BY VERRE ET QUARTZ UVA-FRANCEH & M Douglas Enterprises, Inc.

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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