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510(k) K811419

SPRIO-LOOP by Datamed, Inc. — Product Code BTX

K811419 is an FDA 510(k) premarket notification submitted by Datamed, Inc. for the device "SPRIO-LOOP". The FDA issued a decision of Substantially Equivalent on June 12, 1981. The device falls under product code BTX (Board, Arm (With Cover), Sterile), a Class I device regulated under 21 CFR 878.3910. Datamed, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1981
Date Received
May 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Board, Arm (With Cover), Sterile
Device Class
Class I
Regulation Number
878.3910
Review Panel
SU
Submission Type

Other clearances by Datamed, Inc.

  • K904966 — DATAMED MODEL 401A TRANSRECIEVER (July 18, 1991)
  • K841858 — SPIROLOOP (July 11, 1984)

Other clearances for product code BTX

  • K935098 — BABY BOARD (February 15, 1994)
  • K900175 — 4/1 ARMBOARD (January 24, 1990)
  • K884838 — ALLEN PRONE ARMBOARD (December 15, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K881292 — ALLEN LATERAL ARMBOARD (April 7, 1988)
  • K864670 — BOARD, ARM (WITH COVER) (January 12, 1987)
  • K833664 — ARMBOARD AND THE BOARD (December 27, 1983)
  • K830018 — SAFE-T ARM BOARD (January 26, 1983)
  • K823412 — ARM BOARD W/I.V COVERING (December 15, 1982)
  • K792147 — ARM SHIELD FOR ANESTHESIA (December 6, 1979)

FDA data resources