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510(k) K894555

PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED by Dura Pharmaceuticals, Inc. — Product Code CCQ

K894555 is an FDA 510(k) premarket notification submitted by Dura Pharmaceuticals, Inc. for the device "PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED". The FDA issued a decision of Substantially Equivalent on January 24, 1990. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Dura Pharmaceuticals, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1990
Date Received
July 20, 1989
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

Other clearances by Dura Pharmaceuticals, Inc.

  • K936110 — ASPIRE (March 23, 1995)
  • K896984 — PARI I.S.-2 (March 9, 1990)

Other clearances for product code CCQ

  • K972397 — EZ SPRAY (September 23, 1997)
  • K964956 — E-Z SPACER MASK (SMALL) (April 23, 1997)
  • K961894 — MDI TUTOR (August 14, 1996)
  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • 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)

FDA data resources