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FDA 510(k)

XR-710

K-Number: K800063 · 1980-03-03

ApplicantPennwalt Corp.
Decision Date1980-03-03
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XR-710 is the device name listed in this FDA 510(k) record. The listed applicant is Pennwalt Corp.. It received FDA 510(k) clearance on 1980-03-03 under 510(k) number K800063. 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 XR-710?

XR-710 is a medical device that received FDA 510(k) clearance on 1980-03-03. The listed applicant is Pennwalt Corp.. The 510(k) number is K800063.

When did XR-710 receive FDA 510(k) clearance?

XR-710 received FDA 510(k) clearance on 1980-03-03, under 510(k) number K800063.

Who is the listed applicant for XR-710?

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

What is the FDA product code for XR-710?

The FDA product code for XR-710 is EAP.

Other records listing Pennwalt Corp. 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.

K833241INTREXK801860S.S. WHITE-PENNWALT RENEW CALCIUM HYDROXK801274S.S. WHITE-PENNWALT PRELUDE PIT SEALANTK800133PANOREX II DENTAL X-RAY UNITK780981PORTABLE PNEUMATIC CALIBRATOR 65-150

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

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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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