FDA 510(k) Application Details - K242070

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K242070
Device Name Bronchoscope (Flexible Or Rigid)
Applicant Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 US
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Contact Farzin Bolourchian
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 07/16/2024
Decision Date 09/24/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242070


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