Cleared Special

K000276 - MPT 24 AND VITAL VIEW 24
(FDA 510(k) Clearance)

Mar 2000
Decision
30d
Days
Class 2
Risk

K000276 is an FDA 510(k) clearance for the MPT 24 AND VITAL VIEW 24. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).

Submitted by Criticare Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on March 1, 2000, 30 days after receiving the submission on January 31, 2000.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number K000276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2000
Decision Date March 01, 2000
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2910

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