SMART BAG MO
FDA 510(k) clearance K021328 · decided 2003-06-26
Clearance details
- K-number
- K021328
- Device name
- SMART BAG MO
- Applicant
- O-Two Systems International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-26
- Decision date
- 2003-06-26
- Days to decision
- 426 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.