POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
FDA 510(k) clearance K982127 · decided 1998-06-23
Clearance details
- K-number
- K982127
- Device name
- POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
- Applicant
- Porous Media Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-17
- Decision date
- 1998-06-23
- Days to decision
- 6 days
- Clearance type
- Special
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.