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510(k) K851660

DONWAY LIFTING FRAME by Australian Biomedical Corporation , Ltd. — Product Code FPP

K851660 is an FDA 510(k) premarket notification submitted by Australian Biomedical Corporation , Ltd. for the device "DONWAY LIFTING FRAME". The FDA issued a decision of Substantially Equivalent on August 7, 1985. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900. Australian Biomedical Corporation , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1985
Date Received
April 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Hand-Carried
Device Class
Class I
Regulation Number
880.6900
Review Panel
HO
Submission Type

Other clearances by Australian Biomedical Corporation , Ltd.

  • K871735 — VOROSCOPE(TM) (June 3, 1987)
  • K862457 — LYNX EL MICROSCOPY TISSUE PROCESSOR (July 16, 1986)
  • K853114 — ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR (August 6, 1985)
  • K843522 — DONWAY SPLINT (February 7, 1985)

Other clearances for product code FPP

  • K030283 — BABY POD (April 22, 2003)
  • K942356 — MED-EVAC-4 MEDICAL EVACUATION STRETCHER (July 19, 1994)
  • K940130 — STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER (March 10, 1994)
  • K940245 — EVACU-SLED (February 28, 1994)
  • K924275 — RESTRAINING STRETCHER (July 27, 1993)
  • K922816 — U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER (July 13, 1993)
  • K924669 — FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W (April 29, 1993)
  • K920805 — LIFE LITE EMERGENCY STRETCHER (May 22, 1992)
  • K915874 — BASKET LITTER CARRIER (May 13, 1992)
  • K914140 — GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED (March 31, 1992)

FDA data resources