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510(k) K043287

PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 by Micromedical Devices, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2004
Date Received
November 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Micromedical Devices, Inc.

  • K936195 — LAPAROSCOPES (August 17, 1994)
  • K936155 — ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA (April 11, 1994)
  • K936097 — VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL (March 31, 1994)
  • K936086 — STERILE VIDEO CAMERA COVER AND DRAPE (March 17, 1994)
  • K850791 — MDI 2000 - PULSE GENERATOR (June 19, 1985)
  • K834262 — TRANS-PACE (February 4, 1984)

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