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510(k) K102813

EZONO 3000 by Life-Tech, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2011
Date Received
September 28, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Life-Tech, Inc.

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  • K093662 — ECHOBRIGHT (June 24, 2010)
  • K093485 — VESISCAN (March 16, 2010)
  • K082772 — STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC191 (February 9, 2009)
  • K082056 — ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 (November 7, 2008)
  • K082923 — PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, (October 24, 2008)
  • K081864 — PROLONG (September 25, 2008)
  • K073187 — PERIPHERAL NERVE BLOCK SUPPORT TRAY (April 22, 2008)

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