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

FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #

K Number: K821181 · Decision May 13, 1982
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
21
Applicant Total
8
Review Days
16

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE #
K Number
K821181
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
874.4760
Medical Specialty
Ear, Nose, Throat
Decision
Substantially Equivalent
Applicant
Machida America, Inc.
Date Received
April 27, 1982
Decision Date
May 13, 1982
Product Code
EQN
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
EQN Laryngoscope, Nasopharyngoscope

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (EQN), ordered by most recent decision date.

View all

Other Clearances by Machida America, Inc.

K Number Device Name
K871712 MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.
K854581 MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50
K844834 MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1
K841087 FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000
K821182 MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-
K812734 MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P
K811943 MACHIDA NASOPHARYNGO-LARYNGOSCOPE