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510(k) K827610

ULTRASOUND AUTO SECTOR CARDIAC MODULE by Technicare Corp.

K827610 is an FDA 510(k) premarket notification submitted by Technicare Corp. for the device "ULTRASOUND AUTO SECTOR CARDIAC MODULE". The FDA issued a decision of Substantially Equivalent on July 20, 1982. Technicare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1982
Date Received
June 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Technicare Corp.

  • K854340 — TECHNICARE 720 HPS CT SCANNER (November 15, 1985)
  • K852089 — SATURN NUCLEAR MEDICINE COMPUTER SYSTEM (July 18, 1985)
  • K844293 — AUTO DII MULTI FREQUENCY (February 13, 1985)
  • 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)

FDA data resources