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510(k) K840390

TECHNICARE MODEL 1047 by Technicare Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1984
Date Received
January 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Technicare Corp.

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  • K844247 — ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS (January 23, 1985)
  • K843716 — NUCLEAR 700 MEDICINE MECHANICAL POSIT- (December 17, 1984)
  • K842777 — AUTOFOCUS DUAL ELEMENT PROBE (November 29, 1984)
  • K841817 — TECHNICARE 248 SL & 260SL (August 17, 1984)
  • K840860 — CENTAURI CT SCANNER (May 22, 1984)
  • K840540 — TECHNICARE MODEL 330 (May 9, 1984)
  • K834486 — TECHNICARE 280 (April 13, 1984)

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