Cleared Traditional

PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000

K093298 · Keeler Instruments, Inc. · Ophthalmic
Dec 2010
Decision
415d
Days
Class 2
Risk

About This 510(k) Submission

K093298 is an FDA 510(k) clearance for the PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 10, 2010, 415 days after receiving the submission on October 21, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K093298 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2009
Decision Date December 10, 2010
Days to Decision 415 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKX — Tonometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

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