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510(k) K831731

INFANT EVALUATION CARRIER by E.M. Adams — Product Code FPP

K831731 is an FDA 510(k) premarket notification submitted by E.M. Adams for the device "INFANT EVALUATION CARRIER". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900. E.M. Adams has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1983
Date Received
May 31, 1983
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 E.M. Adams

  • K905173 — SPLASH GUARD (April 25, 1991)
  • K910468 — STERILE DISPOSABLE DRAPE(S) (March 21, 1991)
  • K873978 — DISPOSABLE BIPOLAR FORCEPS (November 23, 1987)
  • K850063 — INSTRUMENT POCKET (February 21, 1985)
  • K843724 — I.V. START KIT & OBSTETRICAL KIT (January 10, 1985)
  • K843783 — WET PACK (December 19, 1984)
  • K843782 — DRY TRAY (December 13, 1984)
  • K843723 — STERILE INSTRUMENT TRAYS-VARIOUS (October 23, 1984)
  • K843115 — STERILE SOLUTION BOWL (September 7, 1984)
  • K843116 — DISPOSABLE SKIN MARKING PEN (August 17, 1984)

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