BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
FDA 510(k) clearance K052087 · decided 2005-12-14
Clearance details
- K-number
- K052087
- Device name
- BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178
- Applicant
- Ag Industries
- Decision
- Substantially Equivalent
- Date received
- 2005-08-02
- Decision date
- 2005-12-14
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Clearwater, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.