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510(k) K861019

CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD by Phase One Disign Co. — Product Code EAK

K861019 is an FDA 510(k) premarket notification submitted by Phase One Disign Co. for the device "CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD". The FDA issued a decision of Substantially Equivalent on April 2, 1986. The device falls under product code EAK (Screen, Leaded, Operator Radiation Protector), a Class I device regulated under 21 CFR 892.6500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1986
Date Received
March 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screen, Leaded, Operator Radiation Protector
Device Class
Class I
Regulation Number
892.6500
Review Panel
RA
Submission Type

Other clearances for product code EAK

  • K952233 — CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (June 16, 1995)
  • K944445 — ED CORP RADIATION SCREEN (May 11, 1995)
  • K944772 — MULTIPLE ED1600 SERIES RADIATION SHIELDS (October 20, 1994)
  • K896949 — MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS (February 16, 1990)
  • K850816 — LEAD PLASTIC VIEWING PANELS (April 10, 1985)
  • K850814 — MODULAR X-RAY BARRIERS (April 10, 1985)

FDA data resources