FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

Rescue Pulmonary Grasping Forceps

K Number: K202987 · Decision Apr 29, 2021
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
6
Review Days
211

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Basic Information

Device Name
Rescue Pulmonary Grasping Forceps
K Number
K202987
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
874.4680
Medical Specialty
Ear, Nose, Throat
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
Date Received
September 30, 2020
Decision Date
April 29, 2021
Product Code
EOQ
Advisory Committee
Ear, Nose, Throat
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EOQ Bronchoscope (Flexible Or Rigid)

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