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FDA 510(k)

R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD

K-Number: K935371 · 1994-12-02

ApplicantR2 Medical Systems
Decision Date1994-12-02
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD is the device name listed in this FDA 510(k) record. The listed applicant is R2 Medical Systems. It received FDA 510(k) clearance on 1994-12-02 under 510(k) number K935371. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD?

R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD is a medical device that received FDA 510(k) clearance on 1994-12-02. The listed applicant is R2 Medical Systems. The 510(k) number is K935371.

When did R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD receive FDA 510(k) clearance?

R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD received FDA 510(k) clearance on 1994-12-02, under 510(k) number K935371.

Who is the listed applicant for R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD?

The FDA 510(k) record lists R2 Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD?

The FDA product code for R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD is DRX.

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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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