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FDA 510(k), K173727, Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
FDA 510(k), K173727, Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
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per
510(K) Number: K173727
Device Name: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
Manufacturer: Ambu A/S
Device Classification Name: bronchoscope (flexible or rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 12/05/2017
Decision Date: 03/28/2018
Regulation Medical Specialty: Ear Nose & Throat
Device Name: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
Manufacturer: Ambu A/S
Device Classification Name: bronchoscope (flexible or rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 12/05/2017
Decision Date: 03/28/2018
Regulation Medical Specialty: Ear Nose & Throat
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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