FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
FDA 510(k) clearance K060382 · decided 2006-04-19
Clearance details
- K-number
- K060382
- Device name
- FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
- Applicant
- Ameriflo Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-14
- Decision date
- 2006-04-19
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- NFB
- Device class
- 2
- Regulation number
- 868.5905
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carmel, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.