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510(k) K932119

CLEVELAND TUBING, INC. VENTILATOR HOSES by Cleveland Tubing, Inc. — Product Code BZO

K932119 is an FDA 510(k) premarket notification submitted by Cleveland Tubing, Inc. for the device "CLEVELAND TUBING, INC. VENTILATOR HOSES". The FDA issued a decision of Substantially Equivalent on June 23, 1993. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Cleveland Tubing, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1993
Date Received
May 3, 1993
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 Cleveland Tubing, Inc.

  • K945314 — CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING (November 18, 1994)
  • K940889 — CONNECTORS AND AIRWAY EXTENSIONS (November 10, 1994)
  • K940890 — CORRUGATED TUBING (November 10, 1994)

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