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510(k) K924551

ENDO TRACHEA TUBE FIXATION by M. Imonti and Associates Inc., — Product Code CBH

K924551 is an FDA 510(k) premarket notification submitted by M. Imonti and Associates Inc., for the device "ENDO TRACHEA TUBE FIXATION". The FDA issued a decision of Substantially Equivalent on December 8, 1992. The device falls under product code CBH (Device, Fixation, Tracheal Tube), a Class I device regulated under 21 CFR 868.5770. M. Imonti and Associates Inc., has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1992
Date Received
September 9, 1992
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 M. Imonti and Associates Inc.,

  • K950800 — PRO-PAK FOR OMS DIPLOMATE (May 22, 1995)
  • K950799 — PRO-VIT (April 28, 1995)
  • K933627 — PHACOFRAGMENTOR TIP (January 25, 1994)
  • K933503 — PRO-PHACO HANDPIECE (January 6, 1994)
  • K905766 — DRAINAGE TUBE RESTRAINT/WOUND COVER (March 6, 1991)

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)

FDA data resources