ERA · Class I · 21 CFR 874.4770

FDA Product Code ERA: Otoscope

Leading manufacturers include Welch Allyn, Inc., Jedmed Instrument Co. and Conphar, Inc..

56
Total
56
Cleared
102d
Avg days
1977
Since

FDA 510(k) Cleared Otoscope Devices (Product Code ERA)

56 devices
1–24 of 56
Cleared Nov 14, 1995
WELCH ALLYN BI-OTOSCOPE
K955043
Welch Allyn, Inc.
Ear, Nose, Throat · 11d
Cleared Jul 10, 1995
WELCH ALLY OTOSCOPE
K952578
Welch Allyn, Inc.
Ear, Nose, Throat · 35d
Cleared Apr 06, 1995
WELCH ALLYN OTOSCOPE
K950787
Welch Allyn, Inc.
Ear, Nose, Throat · 44d
Cleared Nov 18, 1994
OTOVIEW TELESCOPIC OTOSCOPES
K943721
Smith & Nephew, Inc.
Ear, Nose, Throat · 109d
Cleared Sep 23, 1994
VIDEO SCOPE SYSTEM (OTOSCOPE)
K944031
Jedmed Instrument Co.
Ear, Nose, Throat · 37d
Cleared Aug 25, 1994
VIDEOTOSCOPE
K943916
Welch Allyn, Inc.
Ear, Nose, Throat · 14d
Cleared Nov 06, 1992
OTO-BRITE HANDLE
K924025
Jedmed Instrument Co.
Ear, Nose, Throat · 87d
Cleared Sep 04, 1992
STARKEY LABORATORIES OTOSCOPE
K922752
Starkey Laboratories, Inc.
Ear, Nose, Throat · 88d
Cleared Jan 22, 1991
VIDEO OTOSCOPE
K904802
Jedmed Instrument Co.
Ear, Nose, Throat · 90d
Cleared Jan 26, 1990
TYMPANOSCOPE
K896274
Jedmed Instrument Co.
Ear, Nose, Throat · 88d
Cleared Aug 01, 1986
I22 INITIALES
K862621
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 01, 1986
I81 CITE
K862624
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 29, 1985
1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
K851745
Artiberia
Ear, Nose, Throat · 126d
Cleared May 29, 1985
1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.
K851746
Artiberia
Ear, Nose, Throat · 34d
Cleared Jun 30, 1983
AUDIOSCOPE #23000 W/71123 CHARGING STAND
K831709
Welch Allyn, Inc.
Ear, Nose, Throat · 35d
Cleared Jan 19, 1982
CONPHAR OTOSCOPE/OPTHALMASCOPE
K813299
Conphar, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 19, 1982
CONPHAR OTOSCOPE
K813305
Conphar, Inc.
Ear, Nose, Throat · 57d
Cleared Jan 26, 1979
ILLIMINATOR, MODEL 265 NASAL
K782142
Welch Allyn, Inc.
Ear, Nose, Throat · 30d
Cleared Jun 28, 1978
OTOSCOPE, DIAG. MODELS 20100 & 20200
K781029
Welch Allyn, Inc.
Ear, Nose, Throat · 9d
Cleared Apr 29, 1977
OTOSCOPE/ILLUMINATOR, MODEL #21100
K770769
Welch Allyn, Inc.
Ear, Nose, Throat · 1d
Cleared Apr 29, 1977
WALL CHARGER, MODEL #79111
K770770
Welch Allyn, Inc.
Ear, Nose, Throat · 1d

About Product Code ERA - Regulatory Context