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510(k) K850197

KELLER CEPHALOMETRIC DEVICE by Gary D. Keller — Product Code IWY

K850197 is an FDA 510(k) premarket notification submitted by Gary D. Keller for the device "KELLER CEPHALOMETRIC DEVICE". The FDA issued a decision of Substantially Equivalent on March 22, 1985. 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
March 22, 1985
Date Received
January 18, 1985
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)
  • K884847 — MTD HEDREST (January 9, 1989)
  • K864527 — DUOCEPH (January 7, 1987)
  • 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