Bacteria Filter

FDA 510(k) K912577 · Vital Signs, Inc.

Substantially Equivalent

510(k) numberK912577

Submission

Device name
Bacteria Filter
Applicant
Vital Signs, Inc.
Totowa, NJ, US
Received
June 12, 1991
Decision date
April 22, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Bacteria Filter cleared by the FDA?

Bacteria Filter (K912577) received a 510(k) decision of Substantially Equivalent on April 22, 1992, 315 days after the submission was received.

What is the product code of K912577?

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