ETF · Class I · 21 CFR 874.5300

FDA Product Code ETF: Unit, Examining/treatment, Ent

Leading manufacturers include Jedmed Instrument Co., Midmark Corp. and Kelleher Corp..

32
Total
32
Cleared
49d
Avg days
1978
Since

FDA 510(k) Cleared Unit, Examining/treatment, Ent Devices (Product Code ETF)

32 devices
1–24 of 32
Cleared Aug 11, 1995
JEDMED SPECTRUM ENT CABINET
K953457
Jedmed Instrument Co.
Ear, Nose, Throat · 21d
Cleared Jan 18, 1995
PREMIER MIRROR WARMER
K945395
Premier Dental Products Co.
Ear, Nose, Throat · 76d
Cleared Aug 25, 1993
LANGGASSE 90
K932470
Happersberger Otopront GmbH
Ear, Nose, Throat · 97d
Cleared Jul 26, 1991
MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
K911901
Stortz
Ear, Nose, Throat · 88d
Cleared May 15, 1991
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
K910781
Midmark Corp.
Ear, Nose, Throat · 79d
Cleared Apr 17, 1991
MOBILE TREATMENT CART
K910243
Jedmed Instrument Co.
Ear, Nose, Throat · 85d
Cleared Jan 26, 1990
SYSTEMA ENT CABINET
K896273
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Jan 26, 1990
JEDMED S CHAIR
K896298
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Jul 15, 1988
JEDMED MAXIM ENT CABINET
K881958
Jedmed Instrument Co.
Ear, Nose, Throat · 66d
Cleared May 02, 1986
MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
K860940
Micromedics, Inc.
Ear, Nose, Throat · 51d
Cleared Mar 20, 1986
LARYNGEAL MIRROR PRE-WARMER
K855021
Jedmed Instrument Co.
Ear, Nose, Throat · 94d
Cleared Sep 27, 1984
RELIANCE TREATMENT CABINET
K843046
F. & F. Koenigkramer
Ear, Nose, Throat · 56d
Cleared Jan 27, 1984
INSTRUMENT CABINET
K833882
Jedmed Instrument Co.
Ear, Nose, Throat · 79d
Cleared Nov 22, 1982
ENT TREATMENT UNITS
K822252
Kelleher Corp.
Ear, Nose, Throat · 116d
Cleared Nov 22, 1982
SN-100 DOCTOR'S ROUND
K823226
Kells Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 28, 1982
MULTIPLE, ENT CABINET #448
K822531
Midmark Corp.
Ear, Nose, Throat · 36d
Cleared Sep 14, 1982
NAGASHIMA SN-SP UNIT AND CHAIR
K822016
Kelleher Corp.
Ear, Nose, Throat · 68d
Cleared Sep 14, 1982
MULTIPLE, ENT CHAIR #418
K822530
Midmark Corp.
Ear, Nose, Throat · 22d
Cleared Jan 07, 1982
VERSION OF A CLOSED-FLOW SYS. CALORIC
K813490
Thomas M. Foti, M.D.
Ear, Nose, Throat · 34d
Cleared Feb 17, 1981
ATMOSET
K810148
Jedmed Instrument Co.
Ear, Nose, Throat · 27d
Cleared Nov 26, 1980
ENTERMED ENTUNIT
K802712
Jedmed Instrument Co.
Ear, Nose, Throat · 26d
Cleared Aug 13, 1980
NOBLE MEDEL ENT TREATMENT UNIT
K801738
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
NOBLE MODEL DOUBLESIDED TREATMENT UNIT
K801739
Jedmed Instrument Co.
Ear, Nose, Throat · 19d
Cleared Aug 13, 1980
TREATMENT UNIT FOR DOCTOR'S ROUNDS
K801740
Jedmed Instrument Co.
Ear, Nose, Throat · 19d

About Product Code ETF - Regulatory Context