EXPRESS SERIES
FDA 510(k) clearance K070858 · decided 2007-04-16
Clearance details
- K-number
- K070858
- Device name
- EXPRESS SERIES
- Applicant
- Medical Graphics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-28
- Decision date
- 2007-04-16
- Days to decision
- 19 days
- Clearance type
- Special
- Product code
- BZL
- Device class
- 2
- Regulation number
- 868.1730
- 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.