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FDA 510(k)

R1, R2, AND R1+

K-Number: K922954 · 1993-07-22

ApplicantJeneric/Pentron, Inc.
Decision Date1993-07-22
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R1, R2, AND R1+ is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K922954. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R1, R2, AND R1+?

R1, R2, AND R1+ is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K922954.

When did R1, R2, AND R1+ receive FDA 510(k) clearance?

R1, R2, AND R1+ received FDA 510(k) clearance on 1993-07-22, under 510(k) number K922954.

Who is the listed applicant for R1, R2, AND R1+?

The FDA 510(k) record lists Jeneric/Pentron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R1, R2, AND R1+?

The FDA product code for R1, R2, AND R1+ is EJH.

Other records listing Jeneric/Pentron, Inc. as applicant

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Related Devices (Code: EJH)

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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