OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
FDA 510(k) clearance K950853 · decided 1996-11-05
Clearance details
- K-number
- K950853
- Device name
- OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
- Applicant
- Drager, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1995-02-27
- Decision date
- 1996-11-05
- Days to decision
- 617 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Chantilly, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.