FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MODIFIED BRONCHOSCOPE AND ACCESSORIES

K Number: K933433 · Decision Nov 1, 1993
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
30
Review Days
110

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Basic Information

Device Name
MODIFIED BRONCHOSCOPE AND ACCESSORIES
K Number
K933433
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
874.4680
Medical Specialty
Ear, Nose, Throat
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Fujinon, Inc.
Date Received
July 14, 1993
Decision Date
November 1, 1993
Product Code
EOQ
Advisory Committee
Ear, Nose, Throat
Review Advisory Committee
EN
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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Other Clearances by Fujinon, Inc.

K Number Device Name
K120446 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K112391 FUJINON COLONOSCOPES
K102466 FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
K111243 FUJINON ULTRASONIC PROCESSOR
K091773 FUJINON STERILE OVERTUBES
K090116 FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
K063316 FUJINON MODEL EG-530N TRANS NASAL INSERTION
K063847 FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
K050907 FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
K042043 FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
Search all 30 clearances from Fujinon, Inc. →