Home / 510(k) Clearances / K810343

510(k) K810343

NEBULIZERS by Todd Industries, Inc. — Product Code CCQ

K810343 is an FDA 510(k) premarket notification submitted by Todd Industries, Inc. for the device "NEBULIZERS". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Todd Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1981
Date Received
February 10, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type

Other clearances by Todd Industries, Inc.

  • K810373 — VENTURI MASK/DELIVERY SYSTEM #'S (March 17, 1981)
  • K810342 — NASAL CANNULA (March 17, 1981)
  • K810362 — CORRUGATED FLEX TUBING (March 17, 1981)
  • K810339 — NOSECLIP #6118 (March 17, 1981)
  • K810361 — CONNECTOR ADAPTERS (March 17, 1981)
  • K810340 — ADULT MASKS & PEDIATRIC MASKS (March 17, 1981)
  • K810344 — OXYGEN TUBING (March 17, 1981)
  • K810341 — LIFELINE IPPB SET-UP (March 17, 1981)
  • K810430 — VENTURI MASK/DELIVERY SYSTEM #6078 (March 13, 1981)
  • K810374 — CORRUGATED FLEX TUBING #6000, (March 13, 1981)

Other clearances for product code CCQ

  • K972397 — EZ SPRAY (September 23, 1997)
  • K964956 — E-Z SPACER MASK (SMALL) (April 23, 1997)
  • K961894 — MDI TUTOR (August 14, 1996)
  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K960593 — SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIR (May 10, 1996)
  • K922033 — SALINE SOLUTION- STERILE (July 21, 1992)
  • K900576 — MODIFIED AEROCHAMBER WITH MASK (May 13, 1991)
  • K900557 — MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (April 10, 1991)
  • K895115 — FRANK INHALER THERMAL S (May 18, 1990)
  • K894215 — EVOLUTION ULTRASONIC (April 16, 1990)

FDA data resources