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510(k) K946114

SENSORI-MOTOR RATING SCALE by Cmed — Product Code IXY

K946114 is an FDA 510(k) premarket notification submitted by Cmed for the device "SENSORI-MOTOR RATING SCALE". The FDA issued a decision of Substantially Equivalent on April 28, 1995. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Cmed has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1995
Date Received
December 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
Review Panel
RA
Submission Type

Other clearances by Cmed

  • K981157 — STABLE FLOW (June 16, 1998)

Other clearances for product code IXY

  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K922443 — VERT-X UNIVERSAL VERTICAL BUCKY STAND (October 26, 1992)
  • K915667 — MODEL H170 PEDIATRIC CHEST X-RAY UNIT (January 31, 1992)
  • K895034 — BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (November 15, 1989)

FDA data resources