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510(k) K770391

COVER, ARMBOARD, DISPOSABLE by Precept, Inc. — Product Code BTX

K770391 is an FDA 510(k) premarket notification submitted by Precept, Inc. for the device "COVER, ARMBOARD, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on March 7, 1977. The device falls under product code BTX (Board, Arm (With Cover), Sterile), a Class I device regulated under 21 CFR 878.3910. Precept, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1977
Date Received
February 28, 1977
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 Precept, Inc.

  • K771409 — DISP. SURGICAL FACE MASK (October 27, 1977)
  • K770463 — MASK, SURGICAL, FACE, DISPOSABLE (March 23, 1977)
  • K770021 — MASK, FACE, SURGICAL (January 17, 1977)
  • K760360 — SHIRT, MITTEN CUFF INFANT (October 20, 1976)

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)
  • K811419 — SPRIO-LOOP (June 12, 1981)

FDA data resources