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510(k) K803103

TECHNY REX 3000 MOBILE X-RAY UNIT by Tecnomed, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1981
Date Received
December 9, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Tecnomed, Inc.

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  • K827124 — RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHIC (March 5, 1982)
  • K827126 — TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASE (March 5, 1982)
  • K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (March 5, 1982)
  • K820307 — TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE (March 5, 1982)
  • K820305 — RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (March 4, 1982)
  • K827125 — RALCO COLLIMATORS, MANUAL, RADIOGRAPHIC (March 4, 1982)
  • K811197 — SUPERIX 120 (June 9, 1981)
  • K811195 — ARGOSTAT (June 9, 1981)

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