Cleared Traditional

BOEHRINGER MRI SUCTION REGULATORY

K013976 · Boehringer Laboratories · General Hospital
Jan 2002
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K013976 is an FDA 510(k) clearance for the BOEHRINGER MRI SUCTION REGULATORY, a Regulator, Vacuum (Class II — Special Controls, product code KDP), submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on January 8, 2002, 36 days after receiving the submission on December 3, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K013976 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2001
Decision Date January 08, 2002
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KDP — Regulator, Vacuum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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