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510(k) K895016

MODEL #510/515 GENERAL TRANSPORT STRETCHER by Midmark Corp. — Product Code INW

K895016 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "MODEL #510/515 GENERAL TRANSPORT STRETCHER". The FDA issued a decision of Substantially Equivalent on September 11, 1989. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750. Midmark Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1989
Date Received
August 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Mechanical
Device Class
Class I
Regulation Number
890.3750
Review Panel
PM
Submission Type

Other clearances by Midmark Corp.

  • K122643 — VANTAGE MODEL V5000, V5100, V5000C, V5100C (January 7, 2013)
  • K120239 — ELEVANCE (August 24, 2012)
  • K112380 — CLEARVISION (November 22, 2011)
  • K091866 — PROGENY VANTAGE PANORAMIC X-RAY SYSTEM (July 20, 2009)
  • K090670 — MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER (July 7, 2009)
  • K023348 — MIDMARK M9 ULTRACLAVE STEAM STERILIZER (March 3, 2003)
  • K003090 — MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM (October 18, 2000)
  • K992744 — MIDMARK M4*9 EASYCLAVE STEAM STERILIZER (January 10, 2000)
  • K990189 — MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (April 19, 1999)
  • K936181 — MIDMARK M-11 ULTRACLAVE STEAM STERILIZER (November 30, 1994)

Other clearances for product code INW

  • K944308 — JAMES LECKEY FREE STANDER (December 22, 1994)
  • K944307 — JAMES LECKEY PRONE STANDER (December 22, 1994)
  • K943975 — EURO TECH PLATINUM CHIROPRACTIC TABLE (September 29, 1994)
  • K943974 — EURO TECH MARQUISE CHIROPRACTIC TABLE (September 29, 1994)
  • K940238 — TUMBLE FORMS JUNIOR TRISTANDER (March 7, 1994)
  • K932233 — ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405 (July 22, 1993)
  • K932238 — ECO. HI-LOW TREATMENT TABLES VARIOUS MODEL NUMBERS (July 22, 1993)
  • K932231 — ECONOMY HI-LOW MAT TABLE #4110 THRU 4117 (July 22, 1993)
  • K932234 — PROFESSIONAL & ECONMY TILT TABLE 9500 9520 (July 22, 1993)
  • K931635 — TREATMENT TABLES, MANUALLY ACTIVATED (July 21, 1993)

FDA data resources