FDA 510(k)

RX ELAN

K-Number: K840561 · 1984-05-01

Decision Date1984-05-01

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

RX ELAN is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric Ind.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K840561. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RX ELAN?

RX ELAN is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Jeneric Ind.. The 510(k) number is K840561.

When did RX ELAN receive FDA 510(k) clearance?

RX ELAN received FDA 510(k) clearance on 1984-05-01, under 510(k) number K840561.

Who is the listed applicant for RX ELAN?

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

What is the FDA product code for RX ELAN?

The FDA product code for RX ELAN is EJS.

Other records listing Jeneric Ind. 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.

K862822REXILLIUM N. B. F.K862926SURGICAL VITEX K854878H40 BASE METAL ALLOY K844122RX CBG K844123RX CBY K840563RX C & B 20

View all 25 devices →

Related Devices (Code: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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.