Disposable Pulmonary Function Filter

FDA 510(k) K951410 · Creative Biomedics, Inc.

Substantially Equivalent

510(k) numberK951410

Submission

Device name
Disposable Pulmonary Function Filter
Applicant
Creative Biomedics, Inc.
San Clemente, CA, US
Received
March 27, 1995
Decision date
April 24, 1995
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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K221472Filter and HME/FilterCAH · Traditional Ningbo Huakun Medical Equipment Co., Ltd.02/08/2023SE
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More from Great Group Medical Co, Ltd.

510(k)DeviceDecision
K964939The Portable Family - Medi-Facts DX1 Portable Lite and DX1 Portable PlusBZC · Traditional 03/06/1997SE
K951227DX1BZG · Traditional 08/11/1995SE
K951157DX1-PORTABLEBZC · Traditional 08/11/1995SE

Questions and answers

When was Disposable Pulmonary Function Filter cleared by the FDA?

Disposable Pulmonary Function Filter (K951410) received a 510(k) decision of Substantially Equivalent on April 24, 1995, 28 days after the submission was received.

What is the product code of K951410?

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