Filter

FDA 510(k) K970102 · Promedic, Inc.

Substantially Equivalent

510(k) numberK970102

Submission

Device name
Filter
Applicant
Promedic, Inc.
Mccordsville, IN, US
Received
January 13, 1997
Decision date
June 24, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAH – Filter, Bacterial, Breathing-Circuit
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5260
Specialty
Anesthesiology

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Questions and answers

When was Filter cleared by the FDA?

Filter (K970102) received a 510(k) decision of Substantially Equivalent on June 24, 1997, 162 days after the submission was received.

What is the product code of K970102?

The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.