Cleared Traditional

H 5100, H 5200, H 5300

K945507 · Rudolf Riester GmbH & Co. KG · General Hospital
Dec 1994
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K945507 is an FDA 510(k) clearance for the H 5100, H 5200, H 5300, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on December 9, 1994, 30 days after receiving the submission on November 9, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number K945507 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1994
Decision Date December 09, 1994
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KZF — Device, Medical Examination, Ac Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6320

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