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510(k) K913436

PXI PNEUMATIC COMPRESSION PADDLE by Brotherston/Pxi — Product Code IZG

K913436 is an FDA 510(k) premarket notification submitted by Brotherston/Pxi for the device "PXI PNEUMATIC COMPRESSION PADDLE". The FDA issued a decision of Substantially Equivalent on November 5, 1992. The device falls under product code IZG (System, X-Ray, Photofluorographic), a Class II device regulated under 21 CFR 892.1730. Brotherston/Pxi has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1992
Date Received
August 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Photofluorographic
Device Class
Class II
Regulation Number
892.1730
Review Panel
RA
Submission Type

Other clearances by Brotherston/Pxi

  • K913435 — PXI URCD (November 5, 1992)

Other clearances for product code IZG

  • K960082 — DISCOGRAPHY KIT (March 21, 1996)
  • K960146 — G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (February 27, 1996)
  • K920393 — MU125M MOBILE X-RAY SYSTEM (April 6, 1992)
  • K910503 — DISCOGRAPHY KIT (October 7, 1991)
  • K903808 — AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (January 22, 1991)
  • K892659 — ELECTRODELCA (November 21, 1989)

FDA data resources