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FDA 510(k)

RADIOLOGICAL PROTECTIVE EYE SHIELD

K-Number: K920540 · 1992-05-28

ApplicantBurkhart Roentgen Intl., Inc.
Decision Date1992-05-28
Product CodeIWS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOLOGICAL PROTECTIVE EYE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Burkhart Roentgen Intl., Inc.. It received FDA 510(k) clearance on 1992-05-28 under 510(k) number K920540. The device is classified under product code IWS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOLOGICAL PROTECTIVE EYE SHIELD?

RADIOLOGICAL PROTECTIVE EYE SHIELD is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Burkhart Roentgen Intl., Inc.. The 510(k) number is K920540.

When did RADIOLOGICAL PROTECTIVE EYE SHIELD receive FDA 510(k) clearance?

RADIOLOGICAL PROTECTIVE EYE SHIELD received FDA 510(k) clearance on 1992-05-28, under 510(k) number K920540.

Who is the listed applicant for RADIOLOGICAL PROTECTIVE EYE SHIELD?

The FDA 510(k) record lists Burkhart Roentgen Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIOLOGICAL PROTECTIVE EYE SHIELD?

The FDA product code for RADIOLOGICAL PROTECTIVE EYE SHIELD is IWS.

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 Burkhart Roentgen Intl., 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.

K920539ORWO X-RAY FILMK920538PROTECTIVE RADIOGRAFIC GLOVE

Related Devices (Code: IWS)

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.

K945515COATED TUNGSTEN EYESHIELDMedtec, Inc.K940119ROYAL MARSDEN GOLD GRAIN GUNBest IndustriesK943011TUNGSTEN EYESHIELDMedtec, Inc.K934459MED-GENESIS PATIENT LASER EYE SHIELDMed-Genesis, Inc.K934362NUCLEAR ASSOCIATES GLASSERSVictoreen, 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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