Cleared Traditional

K894689 - PENLON IDP PRESSURE FAILURE ALARM
(FDA 510(k) Clearance)

K894689 · Penlon, Inc. · Anesthesiology

Aug 1989

Decision

17d

Days

Class 2

Risk

K894689 is an FDA 510(k) clearance for the PENLON IDP PRESSURE FAILURE ALARM. This device is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP).

Submitted by Penlon, Inc. (Riverside, US). The FDA issued a Cleared decision on August 10, 1989, 17 days after receiving the submission on July 24, 1989.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2600.

Submission Details

510(k) Number	K894689 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 1989
Decision Date	August 10, 1989
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—