Cleared Traditional

K883899 - MANUAL PERCUSSOR CUPS (FDA 510(k) Clearance)

Dec 1988
Decision
89d
Days
Class 2
Risk

K883899 is an FDA 510(k) clearance for the MANUAL PERCUSSOR CUPS. This device is classified as a Percussor, Powered-electric (Class II - Special Controls, product code BYI).

Submitted by Medical Components, Inc. (Anoka, US). The FDA issued a Cleared decision on December 13, 1988, 89 days after receiving the submission on September 15, 1988.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5665.

Submission Details

510(k) Number K883899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date December 13, 1988
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BYI — Percussor, Powered-electric
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.5665