Cleared Traditional

OHMEDA CONTINUOUS SUCTION REGULATOR

K883229 · Ohmeda Medical · General Hospital
Oct 1988
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K883229 is an FDA 510(k) clearance for the OHMEDA CONTINUOUS SUCTION REGULATOR, a Regulator, Vacuum (Class II — Special Controls, product code KDP), submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on October 19, 1988, 79 days after receiving the submission on August 1, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K883229 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1988
Decision Date October 19, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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