Cleared Traditional

K902381 - PENLON BREATHING SYSTEM PRESSURE MONITOR
(FDA 510(k) Clearance)

K902381 · Penlon, Inc. · Toxicology

Aug 1990

Decision

79d

Days

Class 2

Risk

K902381 is an FDA 510(k) clearance for the PENLON BREATHING SYSTEM PRESSURE MONITOR. 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. (Newtown, US). The FDA issued a Cleared decision on August 17, 1990, 79 days after receiving the submission on May 30, 1990.

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

Submission Details

510(k) Number	K902381 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 1990
Decision Date	August 17, 1990
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—