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510(k) K781395

DISPOSABLE AEROSOL T BRIGGS ADAPTOR by Inhal-O-Tech Medical Plastic — Product Code BZA

K781395 is an FDA 510(k) premarket notification submitted by Inhal-O-Tech Medical Plastic for the device "DISPOSABLE AEROSOL T BRIGGS ADAPTOR". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Inhal-O-Tech Medical Plastic has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
August 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
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)
  • 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 BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources