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510(k) K840034

VACUUM STRETCHER IMMOBILIZER by Medicon, Inc. — Product Code FPP

K840034 is an FDA 510(k) premarket notification submitted by Medicon, Inc. for the device "VACUUM STRETCHER IMMOBILIZER". The FDA issued a decision of Substantially Equivalent on February 27, 1984. The device falls under product code FPP (Stretcher, Hand-Carried), a Class I device regulated under 21 CFR 880.6900. Medicon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1984
Date Received
January 5, 1984
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 Medicon, Inc.

  • K962087 — SERVOTRONIC EC100 SYSTEM (April 23, 1997)
  • K952168 — TITANIUM MANDIBULAR FRACTURE SYSTEM (June 22, 1995)
  • K850855 — TENS GB1001 DEVICE (January 9, 1986)
  • K850852 — INFRARAX DEVICE (August 21, 1985)
  • K844702 — GAUZE ASORBABLE (April 1, 1985)
  • K844573 — ABSORBABLE GAUZE PRODUCTS (March 5, 1985)
  • K844574 — WHEELCHAIRS (February 21, 1985)
  • K844703 — GOWNS, SURGICAL (January 10, 1985)
  • K844705 — SHOE COVERS (January 10, 1985)
  • K844704 — CAPS (O.R. NURSE, SURGICAL) (January 10, 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