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FDA 510(k)

HELIODENT MD

K-Number: K950030 · 1995-02-03

ApplicantPelton & Crane Co.
Decision Date1995-02-03
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIODENT MD is the device name listed in this FDA 510(k) record. The listed applicant is Pelton & Crane Co.. It received FDA 510(k) clearance on 1995-02-03 under 510(k) number K950030. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIODENT MD?

HELIODENT MD is a medical device that received FDA 510(k) clearance on 1995-02-03. The listed applicant is Pelton & Crane Co.. The 510(k) number is K950030.

When did HELIODENT MD receive FDA 510(k) clearance?

HELIODENT MD received FDA 510(k) clearance on 1995-02-03, under 510(k) number K950030.

Who is the listed applicant for HELIODENT MD?

The FDA 510(k) record lists Pelton & Crane Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELIODENT MD?

The FDA product code for HELIODENT MD is EAP.

Related Clinical Trials

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.

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Other records listing Pelton & Crane Co. 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.

K972249ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CDK972168SIDEXIS DIGITAL RADIOGRAPHY SYSTEMK945117DELTAK962071SPIRIT S1/S2K960819HELIODENT DSK950299CEREC 2

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Related Devices (Code: EAP)

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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.

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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