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Pari I.S.-2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K896984

by Dura Pharmaceuticals, Inc.

Identifiers

510(k) Number
K896984 FDA 510(k)
FDA Product Code
CAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5630 FDA 510(k)
Regulation Number
868.5630 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SN FDA 510(k)

The Pari I.S.-2 is a medical device classified under the anesthesiology product code CAF. It is designed to function as a respiratory device for clinical applications.

This device was subject to a traditional FDA 510(k) premarket notification process and received clearance on March 9, 1990. It is manufactured by Dura Pharmaceuticals, Inc., based in Ramona, California.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DURA PHARMACEUTICALS, INC. FDA Filings - FDA.report, PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED - fda.report, Dura Pharmaceuticals… — 3 FDA 510 (k)s · DeviceClearance, DURA PHARMACEUTICALS, INC. in San Diego, CA - Bizapedia, 20003423: Dura Pharmaceuticals, Inc.; Spiros Development Corporation II ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dura Pharmaceuticals, Inc.

Sources (1)

  • FDA 510(k) K896984 24 fields · synced Sep 24, 2026