Cleared Traditional

MCINTOSH, MILLER, FOREGGER BABY

K945425 · Rudolf Riester GmbH & Co. KG · Anesthesiology
Mar 1995
Decision
136d
Days
Class 1
Risk

About This 510(k) Submission

K945425 is an FDA 510(k) clearance for the MCINTOSH, MILLER, FOREGGER BABY, a Laryngoscope, Rigid (Class I — General Controls, product code CCW), submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on March 20, 1995, 136 days after receiving the submission on November 4, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number K945425 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1994
Decision Date March 20, 1995
Days to Decision 136 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CCW — Laryngoscope, Rigid
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5540

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