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FDA 510(k)

RIWO DRIVE GENERATOR

K-Number: K984304 · 1999-08-12

Decision Date1999-08-12
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIWO DRIVE GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1999-08-12 under 510(k) number K984304. 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 RIWO DRIVE GENERATOR?

RIWO DRIVE GENERATOR is a medical device that received FDA 510(k) clearance on 1999-08-12. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K984304.

When did RIWO DRIVE GENERATOR receive FDA 510(k) clearance?

RIWO DRIVE GENERATOR received FDA 510(k) clearance on 1999-08-12, under 510(k) number K984304.

Who is the listed applicant for RIWO DRIVE GENERATOR?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIWO DRIVE GENERATOR?

The FDA product code for RIWO DRIVE GENERATOR is HRX.

Related Clinical Trials

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.

Other records listing Richard Wolf Medical Instruments 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.

View all 142 devices →

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.

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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