FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
K Number: K061426
·
Decision Jun 5, 2006
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
9
Review Days
13
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Basic Information
- Device Name
- OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
- K Number
- K061426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Porous Media Corp.
- Date Received
- May 23, 2006
- Decision Date
- June 5, 2006
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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Other Clearances by Porous Media Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K062091 | POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION | Aug 8, 2006 | Substantially Equivalent |
| K990276 | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | Oct 1, 1999 | Substantially Equivalent |
| K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | Feb 1, 1999 | Substantially Equivalent |
| K982127 | POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER | Jun 23, 1998 | Substantially Equivalent |
| K965020 | POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER | Mar 14, 1997 | Substantially Equivalent |
| K964979 | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | Mar 11, 1997 | Substantially Equivalent |
| K952428 | POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER | Jul 7, 1995 | Substantially Equivalent |
| K934132 | POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER | Oct 4, 1994 | Substantially Equivalent |