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510(k) K841637

THREE PORT SENSOR MANIFOLD by Dryden Corp. — Product Code BZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
April 20, 1984
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 Dryden Corp.

  • K880923 — PATIENT VENTILATOR ISOLATOR (September 6, 1988)
  • K880769 — BREATHING CIRCUIT W/HEATED WIRE (August 24, 1988)
  • K882285 — NONREBREATHING CIRCUIT (August 16, 1988)
  • K873928 — UNIVERSAL TOURNIQUET (October 23, 1987)
  • K873927 — REUSEABLE BREATHING TUBES (October 20, 1987)
  • K870859 — BAG-TAIL BLEED VALVE (August 3, 1987)
  • K871386 — BREATHING CIRCUIT (May 29, 1987)
  • K870858 — BADGWELL SAMPLING CATHETER (May 14, 1987)
  • K861540 — DISPOSABLE BERMAN AND GUEDEL AIRWAYS (May 2, 1986)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952011 — PRIMA BREATHING BAGS (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)