Name: Predicase
Price: 199 USD

K-number	K210883
Device name	aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
Applicant	Ambu A/S
Product code	EOQ
Device class	Class II
Decision date	Jun 17, 2021
Decision	Substantially Equivalent
Regulation	874.4680

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Source

View the full FDA submission: accessdata.fda.gov

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aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

Everything you need for a 510(k) submission. Nothing you don't.