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510(k) K771018

TRANS 2000 by Hamilton Industries, Inc. — Product Code INK

K771018 is an FDA 510(k) premarket notification submitted by Hamilton Industries, Inc. for the device "TRANS 2000". The FDA issued a decision of Substantially Equivalent on July 14, 1977. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690. Hamilton Industries, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1977
Date Received
June 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled, Powered
Device Class
Class II
Regulation Number
890.3690
Review Panel
PM
Submission Type

Other clearances by Hamilton Industries, Inc.

  • K883680 — MEDALIST EXAMINATION TABLE (October 4, 1988)
  • K792001 — COMFICARE PAD (FOR SINGEL PT USE) (October 26, 1979)
  • K790871 — ENCLOSED CASE CART (May 14, 1979)
  • K770956 — PAS ANTI-EMBOLISM SYSTEM (September 12, 1977)

Other clearances for product code INK

  • K152056 — Winco Model S550 Stretchair (April 11, 2016)
  • K140095 — PRIME ZOOM STRETCHER (May 20, 2014)
  • K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (September 19, 2011)
  • K110671 — WINCO STRETCHAIR (April 22, 2011)
  • K102236 — HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P (November 18, 2010)
  • K091043 — POWER DRIVE CHAIR, MODEL: TMM6 (May 11, 2009)
  • K051861 — THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 (September 28, 2005)
  • K041924 — HAUSTED POWERTRAN SERIES STRETCHER (September 9, 2004)
  • K022309 — STRYKER POWERED WHEELED STRETCHER (November 8, 2002)
  • K912175 — ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE (June 7, 1991)

FDA data resources