Porous Media DBF23 Reusable Respiratory Filter
FDA 510(k) K965020 · Porous Media Corp.
510(k) numberK965020
Submission
- Device name
- Porous Media DBF23 Reusable Respiratory Filter
- Applicant
- Porous Media Corp.
St. Paul, MN, US - Received
- December 16, 1996
- Decision date
- March 14, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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More from Great Group Medical Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K062091 | Porous Media Humidiflow Humidifier for Universal HumidificationBTT · Traditional | 08/08/2006SE |
| K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47CAH · Traditional | 06/05/2006SE |
| K990276 | Porous Media DPB30 Series Disposable Pre-Bypass FilterKRJ · Traditional | 10/01/1999SE |
| K982385 | Porous Media DPB20 Series Disposable Pre-Bypass FilterKRJ · Traditional | 02/01/1999SE |
| K982127 | Porous Media DEF25 Disposable Respiratory FilterCAH · Special | 06/23/1998SE |
| K964979 | Porous Media DBF23 Disposable Respiratory FilterCAH · Traditional | 03/11/1997SE |
| K952428 | Porous Media DBF23-R Reusable Respiratory FilterCAH · Traditional | 07/07/1995SE |
| K934132 | Porous Media DBF23 Disposable Respiratory FilterCAH · Traditional | 10/04/1994SE |
Questions and answers
When was Porous Media DBF23 Reusable Respiratory Filter cleared by the FDA?
Porous Media DBF23 Reusable Respiratory Filter (K965020) received a 510(k) decision of Substantially Equivalent on March 14, 1997, 88 days after the submission was received.
What is the product code of K965020?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.