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FDA 510(k)

KELLER CEPHALOMETRIC DEVICE

K-Number: K850197 · 1985-03-22

ApplicantGary D. Keller
Decision Date1985-03-22
Product CodeIWY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KELLER CEPHALOMETRIC DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Gary D. Keller. It received FDA 510(k) clearance on 1985-03-22 under 510(k) number K850197. The device is classified under product code IWY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KELLER CEPHALOMETRIC DEVICE?

KELLER CEPHALOMETRIC DEVICE is a medical device that received FDA 510(k) clearance on 1985-03-22. The listed applicant is Gary D. Keller. The 510(k) number is K850197.

When did KELLER CEPHALOMETRIC DEVICE receive FDA 510(k) clearance?

KELLER CEPHALOMETRIC DEVICE received FDA 510(k) clearance on 1985-03-22, under 510(k) number K850197.

Who is the listed applicant for KELLER CEPHALOMETRIC DEVICE?

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

What is the FDA product code for KELLER CEPHALOMETRIC DEVICE?

The FDA product code for KELLER CEPHALOMETRIC DEVICE is IWY.

Related Clinical Trials

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Related Devices (Code: IWY)

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.

K925705ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEMDenar Corp.K884493HEAD HOLDING DEVICE/SLEEP APNEAX-Ray SystemsK884847MTD HEDRESTComposites Horizons, Inc.K864527DUOCEPHGary E. Hall, DdsK844549HEAD-SPINE STABILIZER HSS-1Imaging Accessories, Inc.K843340PORTA-STATPorta-Stat, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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