Cleared Traditional

K897059 - HOOD SPEAKING VALVE
(FDA 510(k) Clearance)

K897059 · Hood Laboratories · Anesthesiology
Mar 1990
Decision
84d
Days
Class 2
Risk

K897059 is an FDA 510(k) clearance for the HOOD SPEAKING VALVE. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH).

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 12, 1990, 84 days after receiving the submission on December 18, 1989.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K897059 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1989
Decision Date March 12, 1990
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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