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510(k) K940442

MPR-814 by Xri, Inc. — Product Code IYB

K940442 is an FDA 510(k) premarket notification submitted by Xri, Inc. for the device "MPR-814". The FDA issued a decision of Substantially Equivalent on June 9, 1994. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1994
Date Received
February 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
Review Panel
RA
Submission Type

Other clearances for product code IYB

  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K935004 — MODEL ALPHA TS-2 (December 13, 1993)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)
  • K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIES (December 7, 1992)
  • K920727 — CEILING TUBE SUPPORT CH-30X (April 16, 1992)
  • K914944 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 2, 1991)

FDA data resources