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FDA 510(k)

ARTHRO AUTOMAT 5002

K-Number: K871180 · 1987-09-29

ApplicantF.M. Wiest USA, Inc.
Decision Date1987-09-29
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHRO AUTOMAT 5002 is the device name listed in this FDA 510(k) record. The listed applicant is F.M. Wiest USA, Inc.. It received FDA 510(k) clearance on 1987-09-29 under 510(k) number K871180. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHRO AUTOMAT 5002?

ARTHRO AUTOMAT 5002 is a medical device that received FDA 510(k) clearance on 1987-09-29. The listed applicant is F.M. Wiest USA, Inc.. The 510(k) number is K871180.

When did ARTHRO AUTOMAT 5002 receive FDA 510(k) clearance?

ARTHRO AUTOMAT 5002 received FDA 510(k) clearance on 1987-09-29, under 510(k) number K871180.

Who is the listed applicant for ARTHRO AUTOMAT 5002?

The FDA 510(k) record lists F.M. Wiest USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHRO AUTOMAT 5002?

The FDA product code for ARTHRO AUTOMAT 5002 is HRX.

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Other records listing F.M. Wiest USA, Inc. as applicant

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Related Devices (Code: HRX)

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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