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FDA 510(k)

R2+

K-Number: K934758 · 1994-02-18

ApplicantJeneric/Pentron, Inc.
Decision Date1994-02-18
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R2+ 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 1994-02-18 under 510(k) number K934758. 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 R2+?

R2+ is a medical device that received FDA 510(k) clearance on 1994-02-18. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K934758.

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

R2+ received FDA 510(k) clearance on 1994-02-18, under 510(k) number K934758.

Who is the listed applicant for R2+?

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 R2+?

The FDA product code for R2+ 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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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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