NARKOMED MRI-2, MODEL NM-MRI-2
FDA 510(k) clearance K003579 · decided 2001-01-22
Clearance details
- K-number
- K003579
- Device name
- NARKOMED MRI-2, MODEL NM-MRI-2
- Applicant
- Draeger Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-20
- Decision date
- 2001-01-22
- Days to decision
- 63 days
- Clearance type
- Special
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.