INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
FDA 510(k) clearance K040188 · decided 2004-04-14
Clearance details
- K-number
- K040188
- Device name
- INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-28
- Decision date
- 2004-04-14
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- NHP
- Device class
- 2
- Regulation number
- 868.1500
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.