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FDA 510(k)

GENERATOR, R-WAVE

K-Number: K790213 · 1979-03-22

ApplicantAmr Co.
Decision Date1979-03-22
Product CodeIYY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENERATOR, R-WAVE is the device name listed in this FDA 510(k) record. The listed applicant is Amr Co.. It received FDA 510(k) clearance on 1979-03-22 under 510(k) number K790213. The device is classified under product code IYY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERATOR, R-WAVE?

GENERATOR, R-WAVE is a medical device that received FDA 510(k) clearance on 1979-03-22. The listed applicant is Amr Co.. The 510(k) number is K790213.

When did GENERATOR, R-WAVE receive FDA 510(k) clearance?

GENERATOR, R-WAVE received FDA 510(k) clearance on 1979-03-22, under 510(k) number K790213.

Who is the listed applicant for GENERATOR, R-WAVE?

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

What is the FDA product code for GENERATOR, R-WAVE?

The FDA product code for GENERATOR, R-WAVE is IYY.

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Related Devices (Code: IYY)

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.

K853737VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)Capintec, Inc.K780510NUCLEAR STETHOSCOPEBios, 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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