FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1— 510(k) K060382

Substantially Equivalent

Ameriflo Corp.

FDA 510(k) clearance K060382 for FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1, Substantially Equivalent on 2006-04-19. Applicant: Ameriflo Corp.. Device class: 2.

Clearance details

Applicant
Ameriflo Corp.
Product code
Code NFB
Device class
Class 2
Regulation
21 CFR 868.5905
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Carmel, IN, US
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