Device Listing 1135697882

Listing Summary#

Listing key
1135697882
Premarket submission
K983183
Device
GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
Applicant
Bien Air USA, Inc.
Product code
EFB
Decision date
1998-12-10