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510(k) K884493

HEAD HOLDING DEVICE/SLEEP APNEA by X-Ray Systems — Product Code IWY

K884493 is an FDA 510(k) premarket notification submitted by X-Ray Systems for the device "HEAD HOLDING DEVICE/SLEEP APNEA". The FDA issued a decision of Substantially Equivalent on January 12, 1989. The device falls under product code IWY (Holder, Head, Radiographic), a Class I device regulated under 21 CFR 892.1920. X-Ray Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1989
Date Received
October 26, 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 by X-Ray Systems

  • K855161 — UPRIGHT BUCKY STAND/MOUNT (February 12, 1986)
  • K855052 — TABLE RADIOGRAPHIC FIXED (February 6, 1986)
  • K853682 — MOUNT TUBE RADIOGRAPHIC (September 19, 1985)

Other clearances for product code IWY

  • K925705 — ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM (December 28, 1992)
  • K884847 — MTD HEDREST (January 9, 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