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510(k) K903618

ROBERTAZZI NASOPHARYNGEAL AIRWAY by Eastmed Enterprises, Inc. — Product Code BTQ

K903618 is an FDA 510(k) premarket notification submitted by Eastmed Enterprises, Inc. for the device "ROBERTAZZI NASOPHARYNGEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on January 8, 1991. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Eastmed Enterprises, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1991
Date Received
August 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Nasopharyngeal
Device Class
Class I
Regulation Number
868.5100
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)
  • K901489 — MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) (April 10, 1990)
  • 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 BTQ

  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K901279 — CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY (March 28, 1990)
  • K883668 — SUNDERLAND NASAL TUBE (November 21, 1988)
  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K871673 — NASOPHARYNGEAL AIRWAY (June 15, 1987)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)

FDA data resources