EMS HEPA FILTER AND HME COMBINATIONS
FDA 510(k) clearance K013089 · decided 2002-03-14
Clearance details
- K-number
- K013089
- Device name
- EMS HEPA FILTER AND HME COMBINATIONS
- Applicant
- Engineered Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2001-09-17
- Decision date
- 2002-03-14
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mccordsville, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.