Cleared Traditional

PIVOTING COMPENSATING FILTERS FOR THE HEAD

K972766 · Octostop, Inc. · Radiology
Aug 1997
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K972766 is an FDA 510(k) clearance for the PIVOTING COMPENSATING FILTERS FOR THE HEAD, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Octostop, Inc. (Montreal, Qc., CA). The FDA issued a Cleared decision on August 14, 1997, 21 days after receiving the submission on July 24, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K972766 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1997
Decision Date August 14, 1997
Days to Decision 21 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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