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510(k) K961455

MEDSHIELD/AEROCHAMBER by Diemolding Corp. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1996
Date Received
April 16, 1996
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

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  • K902114 — CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR (July 18, 1990)
  • K900754 — RESPIREX 2 (March 15, 1990)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K781759 — RESCAL (November 27, 1978)
  • K780750 — O2 CONNECTOR (July 27, 1978)
  • K770369 — VACON TM (March 1, 1977)
  • K760931 — I.V. DRIP MONITOR ALARM DEVICE, MONIFLO (January 5, 1977)
  • K760636 — ORTHOMIX (October 5, 1976)

Other clearances for product code CCQ

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  • 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)
  • K894555 — PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED (January 24, 1990)