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510(k) K914251

MODEL IRC PASSPORT NEBULIZER by Invacare Corp. — Product Code LAW

K914251 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "MODEL IRC PASSPORT NEBULIZER". The FDA issued a decision of Substantially Equivalent on January 24, 1992. The device falls under product code LAW (Theophylline Control Materials), a Class I device regulated under 21 CFR 862.3280. Invacare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1992
Date Received
September 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Theophylline Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Invacare Corp.

  • K071928 — THE INVACARE FLYER, MODEL IPC 100 (December 12, 2007)
  • K070321 — TWILIGHT FULL FACE MASK (April 30, 2007)
  • K062402 — EASYSTAND EVOLV (September 21, 2006)
  • K061874 — INVACARE'S TWILIGHT II NASAL MASKS (September 5, 2006)
  • K033819 — INVACARE 3G TARSYS (June 4, 2004)
  • K031176 — INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (March 25, 2004)
  • K031064 — INVACARE POLARIS EX CPAP, MODEL ISP3000 (March 12, 2004)
  • K030814 — INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 (March 20, 2003)
  • K022642 — TWLIGHT, MODEL ISP 9600 (February 11, 2003)
  • K023589 — STORM TDX POWER WHEELCHAIR (November 19, 2002)

Other clearances for product code LAW

  • K920223 — CHEM CHEX THEOPHYLLINE CONTROL (June 10, 1992)
  • K903924 — BIOTRACK THEOPHYLLINE QUALITY CONTROLS (September 17, 1990)
  • K871589 — THEOPHYLLINE FPIA CONTROLS (June 17, 1987)

FDA data resources