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510(k) K920540

RADIOLOGICAL PROTECTIVE EYE SHIELD by Burkhart Roentgen Intl., Inc. — Product Code IWS

K920540 is an FDA 510(k) premarket notification submitted by Burkhart Roentgen Intl., Inc. for the device "RADIOLOGICAL PROTECTIVE EYE SHIELD". The FDA issued a decision of Substantially Equivalent on May 28, 1992. The device falls under product code IWS (Shield, Eye, Radiological), a Class I device regulated under 21 CFR 892.6500. Burkhart Roentgen Intl., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1992
Date Received
February 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Eye, Radiological
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances by Burkhart Roentgen Intl., Inc.

  • K920539 — ORWO X-RAY FILM (June 30, 1992)
  • K920538 — PROTECTIVE RADIOGRAFIC GLOVE (May 29, 1992)

Other clearances for product code IWS

  • K945515 — COATED TUNGSTEN EYESHIELD (June 19, 1995)
  • K940119 — ROYAL MARSDEN GOLD GRAIN GUN (December 30, 1994)
  • K943011 — TUNGSTEN EYESHIELD (December 23, 1994)
  • K934459 — MED-GENESIS PATIENT LASER EYE SHIELD (February 22, 1994)
  • K934362 — NUCLEAR ASSOCIATES GLASSERS (November 12, 1993)

FDA data resources