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510(k) K894987

MODEL #520/525 ED/RECOVERY STRETCHER by Medmark, Inc. — Product Code INW

K894987 is an FDA 510(k) premarket notification submitted by Medmark, Inc. for the device "MODEL #520/525 ED/RECOVERY STRETCHER". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750. Medmark, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 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 Medmark, Inc.

  • K914498 — POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES (November 27, 1991)
  • K893949 — #157 EXAM LIGHT (August 7, 1989)

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