Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RX 91

K-Number: K823100 · 1982-11-10

ApplicantBauer, Cheng & Associates, Inc.
Decision Date1982-11-10
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RX 91 is the device name listed in this FDA 510(k) record. The listed applicant is Bauer, Cheng & Associates, Inc.. It received FDA 510(k) clearance on 1982-11-10 under 510(k) number K823100. 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 91?

RX 91 is a medical device that received FDA 510(k) clearance on 1982-11-10. The listed applicant is Bauer, Cheng & Associates, Inc.. The 510(k) number is K823100.

When did RX 91 receive FDA 510(k) clearance?

RX 91 received FDA 510(k) clearance on 1982-11-10, under 510(k) number K823100.

Who is the listed applicant for RX 91?

The FDA 510(k) record lists Bauer, Cheng & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RX 91?

The FDA product code for RX 91 is EJS.

Other records listing Bauer, Cheng & Associates, Inc. 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.

K840084COLTENE BRILLIANT LUXK840085COLTENE BRILLIANTK823098REX-CAPSK823097NATURELLEK823084CHALLENGERK823099RX MIDACAST

View all 11 devices →

Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR 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.

↑