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510(k) K770354

TUBING, AEROSAL, DISPOSABLE by Inhal-O-Tech Medical Plastic — Product Code BZO

K770354 is an FDA 510(k) premarket notification submitted by Inhal-O-Tech Medical Plastic for the device "TUBING, AEROSAL, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on March 16, 1977. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Inhal-O-Tech Medical Plastic has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1977
Date Received
February 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing And Support, Ventilator (W Harness)
Device Class
Class I
Regulation Number
868.5975
Review Panel
AN
Submission Type

Other clearances by Inhal-O-Tech Medical Plastic

  • K781741 — MASK, BI FLO NASAL OXYGEN (December 1, 1978)
  • K781394 — DISPOSABLE INCENTIVE SPIROMETER (October 16, 1978)
  • K781395 — DISPOSABLE AEROSOL T BRIGGS ADAPTOR (August 31, 1978)
  • 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 BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K945740 — INFANT FLOW SYSTEM (March 23, 1995)
  • K944531 — PRIMA, INC. CORRUGATED TUBING (December 2, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)

FDA data resources