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510(k) K896949

MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS by Innovative Products Mfg. — Product Code EAK

K896949 is an FDA 510(k) premarket notification submitted by Innovative Products Mfg. for the device "MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS". The FDA issued a decision of Substantially Equivalent on February 16, 1990. 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
February 16, 1990
Date Received
December 13, 1989
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)
  • K861019 — CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD (April 2, 1986)
  • K850816 — LEAD PLASTIC VIEWING PANELS (April 10, 1985)
  • K850814 — MODULAR X-RAY BARRIERS (April 10, 1985)

FDA data resources