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510(k) K884847

MTD HEDREST by Composites Horizons, Inc. — Product Code IWY

K884847 is an FDA 510(k) premarket notification submitted by Composites Horizons, Inc. for the device "MTD HEDREST". The FDA issued a decision of Substantially Equivalent on January 9, 1989. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1989
Date Received
November 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Radiographic
Device Class
Class I
Regulation Number
892.1920
Review Panel
RA
Submission Type

Other clearances for product code IWY

  • K925705 — ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM (December 28, 1992)
  • K884493 — HEAD HOLDING DEVICE/SLEEP APNEA (January 12, 1989)
  • K864527 — DUOCEPH (January 7, 1987)
  • K850197 — KELLER CEPHALOMETRIC DEVICE (March 22, 1985)
  • K844549 — HEAD-SPINE STABILIZER HSS-1 (March 1, 1985)
  • K843340 — PORTA-STAT (November 27, 1984)
  • K834559 — DELUXE WALL-MOUNTED CEPHALOMETER (February 21, 1984)
  • K802140 — LEKSELL STEREOTACTIC SYSTEM (February 5, 1981)
  • K772313 — X-RAY CO-ORDINATOR (January 30, 1978)

FDA data resources