Cleared Traditional

K930509 - PM PUMP COMPRESSOR
(FDA 510(k) Clearance)

K930509 · Precision Medical, Inc. · Anesthesiology device

Oct 1994

Decision

634d

Days

Class 2

Risk

K930509 is an FDA 510(k) clearance for the PM PUMP COMPRESSOR. This device is classified as a Compressor, Air, Portable (Class II - Special Controls, product code BTI).

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on October 28, 1994, 634 days after receiving the submission on February 1, 1993.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6250.

Submission Details

510(k) Number	K930509 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 01, 1993
Decision Date	October 28, 1994
Days to Decision	634 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement