Cleared Traditional

SPAN-AID BRIDGING PILLOW SYSTEM

K801518 · Span-America Medical Systems, Inc. · Ophthalmic
Aug 1980
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K801518 is an FDA 510(k) clearance for the SPAN-AID BRIDGING PILLOW SYSTEM, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Span-America Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1980, 34 days after receiving the submission on July 1, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K801518 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1980
Decision Date August 04, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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