Home / 510(k) Clearances / K781394

510(k) K781394

DISPOSABLE INCENTIVE SPIROMETER by Inhal-O-Tech Medical Plastic — Product Code CCQ

K781394 is an FDA 510(k) premarket notification submitted by Inhal-O-Tech Medical Plastic for the device "DISPOSABLE INCENTIVE SPIROMETER". The FDA issued a decision of Substantially Equivalent on October 16, 1978. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Inhal-O-Tech Medical Plastic has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1978
Date Received
August 14, 1978
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 Inhal-O-Tech Medical Plastic

  • K781741 — MASK, BI FLO NASAL OXYGEN (December 1, 1978)
  • K781395 — DISPOSABLE AEROSOL T BRIGGS ADAPTOR (August 31, 1978)
  • K770354 — TUBING, AEROSAL, DISPOSABLE (March 16, 1977)
  • K770353 — DISPOSABLE TEMPERATURE PROBE (March 16, 1977)
  • K760329 — MASK, DISPOSABLE OXYGEN THERAPY (September 30, 1976)
  • K760330 — CANNULA, DISPOSABLE OXYGEN TTHERAPY (August 4, 1976)

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