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510(k) K930249

BC/WT/PF by Tingle X-Ray Products, Inc. — Product Code IXY

K930249 is an FDA 510(k) premarket notification submitted by Tingle X-Ray Products, Inc. for the device "BC/WT/PF". The FDA issued a decision of Substantially Equivalent on April 27, 1993. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Tingle X-Ray Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1993
Date Received
January 19, 1993
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 Tingle X-Ray Products, Inc.

  • K926554 — 525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR (May 17, 1993)
  • K860203 — TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR (January 30, 1986)

Other clearances for product code IXY

  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (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