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510(k) K901489

MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) by Eastmed Enterprises, Inc. — Product Code CCW

K901489 is an FDA 510(k) premarket notification submitted by Eastmed Enterprises, Inc. for the device "MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)". The FDA issued a decision of Substantially Equivalent on April 10, 1990. The device falls under product code CCW (Laryngoscope, Rigid), a Class I device regulated under 21 CFR 868.5540. Eastmed Enterprises, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
March 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Rigid
Device Class
Class I
Regulation Number
868.5540
Review Panel
AN
Submission Type

Other clearances by Eastmed Enterprises, Inc.

  • K922019 — LARYNGOSCOPE RIGID (January 26, 1993)
  • K921128 — ENDOTRACHEAL TUBE STYLET (June 2, 1992)
  • K914741 — AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED (February 3, 1992)
  • K903618 — ROBERTAZZI NASOPHARYNGEAL AIRWAY (January 8, 1991)
  • K890342 — AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) (April 27, 1989)
  • K884584 — TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (November 14, 1988)
  • K884073 — LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) (October 13, 1988)
  • K884072 — 15 MILLIMETER MALE AND FEMALE ADAPTERS (October 7, 1988)
  • K882433 — LARYNGOSCOPE RIGID (September 2, 1988)
  • K882434 — MASK, GAS, ANESTHETIC (June 30, 1988)

Other clearances for product code CCW

  • K191602 — APA Oxy Blade (August 2, 2019)
  • K163412 — Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (June 22, 2017)
  • K140951 — YEESCOPE LARYNGOSCOPES (November 10, 2014)
  • K121378 — AIRTRAQ SP AIRTRAQ AVANT (June 21, 2012)
  • K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (February 9, 2007)
  • K062523 — TRU-MR LARYNGOSCOPE SET (November 17, 2006)
  • K062231 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 (August 31, 2006)
  • K062230 — MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 (August 31, 2006)
  • K041852 — MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 (November 15, 2004)
  • K984101 — FLEXIBLADE (September 3, 1999)

FDA data resources