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510(k) K945163

ECHOCARDIOGRAPHY by Tri W-G, Inc. — Product Code LGX

K945163 is an FDA 510(k) premarket notification submitted by Tri W-G, Inc. for the device "ECHOCARDIOGRAPHY". The FDA issued a decision of Substantially Equivalent on February 17, 1995. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. Tri W-G, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1995
Date Received
October 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Examination, Medical, Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
HO
Submission Type

Other clearances by Tri W-G, Inc.

  • K960196 — TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 (February 7, 1996)
  • K941720 — MODEL 747 AND 747-30 EXAM/TREATMENT TABLE (May 6, 1994)
  • K936303 — TREATMENT TABLE MODIFICATION (March 18, 1994)
  • K933119 — HI-LO TREATMENT TABLES (October 12, 1993)
  • K932746 — MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE (July 21, 1993)
  • K930802 — MODELS 642 & 643 TILT EXAM/TREATMENT TABLE (March 22, 1993)
  • K925594 — MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE (February 12, 1993)
  • K923325 — MODEL 600 MEDICAL TREATMENT TABLE (July 21, 1992)
  • K922980 — 745-M (MAGNUM) (July 13, 1992)
  • K920585 — MAT TABLE, 8100 SERIES MAT PLATFORM (April 7, 1992)

Other clearances for product code LGX

  • K894144 — POWER EXAMINATION TABLE MODEL # 405 (August 28, 1989)
  • K894134 — POWER EXAMINATION TABLE MODEL # 411 (August 28, 1989)
  • K883680 — MEDALIST EXAMINATION TABLE (October 4, 1988)
  • K882010 — POWER EXAMINATION TABLE (July 13, 1988)
  • K864072 — ADEC 1005-C CHAIR (November 7, 1986)
  • K860519 — RELIANCE MODEL 200 PODIATRY CHAIR (February 19, 1986)
  • K845023 — STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 (January 28, 1985)
  • K830294 — MEDICAL EXAM TABLE (January 11, 1984)
  • K832768 — S & W SW52E W/POWER BACK LIFT (September 20, 1983)
  • K820823 — MULTIPLE, MODEL #17 (April 21, 1982)

FDA data resources