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FDA 510(k)

CHALLENGER

K-Number: K823084 · 1982-11-10

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

Device Summary

CHALLENGER 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 K823084. 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 CHALLENGER?

CHALLENGER 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 K823084.

When did CHALLENGER receive FDA 510(k) clearance?

CHALLENGER received FDA 510(k) clearance on 1982-11-10, under 510(k) number K823084.

Who is the listed applicant for CHALLENGER?

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 CHALLENGER?

The FDA product code for CHALLENGER is EJS.

Related Clinical Trials

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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 BRILLIANTK823100RX 91K823097NATURELLEK823098REX-CAPSK823099RX 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.

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