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510(k) K820574

ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL by David Simmonds Co., Inc. — Product Code BWN

K820574 is an FDA 510(k) premarket notification submitted by David Simmonds Co., Inc. for the device "ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL". The FDA issued a decision of Substantially Equivalent on March 23, 1982. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. David Simmonds Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1982
Date Received
March 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by David Simmonds Co., Inc.

  • K822848 — PRIMARY & SECONDARY I.V. TUBING SETS (October 15, 1982)
  • K820527 — ANESTHESIA EXTENSION TUBES (March 18, 1982)

Other clearances for product code BWN

  • K942699 — AIRFRAME SURGICAL DRAPE SUPPORT (July 13, 1994)
  • K935441 — INFINITECH BREATH EZ (February 7, 1994)
  • K925005 — ISI SELF-SUPPORTING ARM (April 29, 1993)
  • K922288 — HOLDER, PEDIATRIC POSITION (February 10, 1993)
  • K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (April 2, 1991)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K884558 — IOP ADJUSTABLE STIRRUP (November 17, 1988)
  • K875291 — SPINAL SURGERY FRAME (January 22, 1988)
  • K873272 — ENDOSCOPY TABLE 1532 ENDOSTAR (September 8, 1987)
  • K860177 — ALLEN UNIVERSAL STIRRUP (February 11, 1986)

FDA data resources