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510(k) K902896

49-610 NIKO-NOSE FIXATION TAPE by Nikomed U.S.A., Inc. — Product Code CBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1990
Date Received
July 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
Review Panel
AN
Submission Type

Other clearances by Nikomed U.S.A., Inc.

  • K022909 — NIKOMED TRACE 1 ECG ELECTRODES (January 9, 2003)
  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K950473 — DISPOSABLE ECG MONITORING ELECTRODE (December 12, 1995)
  • K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM (November 14, 1995)
  • K950475 — DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 (November 14, 1995)
  • K950471 — DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM (November 6, 1995)
  • K950470 — DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM (November 6, 1995)
  • K950480 — DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM (November 6, 1995)
  • K950474 — DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM (November 6, 1995)
  • K950477 — DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM (November 6, 1995)

Other clearances for product code CBH

  • K140097 — AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM (September 24, 2014)
  • K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/280 (January 28, 1997)
  • K942529 — HCI TUBE STABILIZER (June 14, 1995)
  • K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (April 24, 1995)
  • K950930 — TRACHE-TITE (March 22, 1995)
  • K950318 — FLEX BLUE (February 13, 1995)
  • K942395 — ENDOTRACHEAL TUBE HOLDER (June 30, 1994)
  • K934288 — HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (June 9, 1994)
  • K942016 — TRACH TIE, VENTILATOR TUBING HOLDER (May 24, 1994)
  • K941384 — TRAKEEZ (April 19, 1994)