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FDA 510(k)

HELIODENT DS

K-Number: K960819 · 1996-03-29

ApplicantPelton & Crane Co.
Decision Date1996-03-29
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIODENT DS 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 1996-03-29 under 510(k) number K960819. 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 DS?

HELIODENT DS is a medical device that received FDA 510(k) clearance on 1996-03-29. The listed applicant is Pelton & Crane Co.. The 510(k) number is K960819.

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

HELIODENT DS received FDA 510(k) clearance on 1996-03-29, under 510(k) number K960819.

Who is the listed applicant for HELIODENT DS?

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 DS?

The FDA product code for HELIODENT DS 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/S2K950299CEREC 2K946187SPIRIT II AND SPIRIT TREATMENT CENTER

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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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