HKX · Class II · 21 CFR 886.1930

FDA Product Code HKX: Tonometer, Ac-powered

Leading manufacturers include Bio-Rad, Keeler Instruments, Inc. and CooperVision, Inc..

58
Total
58
Cleared
146d
Avg days
1980
Since
58 devices
25–48 of 58
Cleared Jun 27, 2001
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
K010998
Langham Ophthalmic Technologies
Ophthalmic · 85d
Cleared Dec 11, 2000
MODEL 30 CLASSIC PNEUMATONOMETER
K002395
Xomed, Inc.
Ophthalmic · 126d
Cleared Oct 18, 2000
SMARTLENS
K002510
Odc Ophthalmic Development Co. AG
Ophthalmic · 64d
Cleared Jun 07, 1999
LEICA AT550
K990869
Leica Microsystems, Inc.
Ophthalmic · 83d
Cleared Mar 25, 1999
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257
Keeler Instruments, Inc.
Ophthalmic · 57d
Cleared Mar 03, 1997
CANON TX-10 TONOMETER
K963079
Canon USA, Inc.
Ophthalmic · 208d
Cleared Aug 22, 1995
ZEIMER SELF TONOMETER
K953031
Cds Technologies
Ophthalmic · 90d
Cleared Aug 17, 1995
DIGITAL AVERAGING TONOMETER
K945972
Opti-Med Electronics
Ophthalmic · 252d
Cleared May 12, 1995
NON-CONTACT TONOMETER T-2
K943939
Canon, Inc.
Ophthalmic · 273d
Cleared Sep 29, 1994
XPERT NCT
K941865
Reichert Ophthalmic Instruments, Div. Leica, Inc.
Ophthalmic · 164d
Cleared Jun 22, 1993
TIP & MEMBRANE ASSEMBLY
K921443
Bio-Rad
Ophthalmic · 483d
Cleared Apr 05, 1993
BURTON APPLANATION TONOMETER - MODEL T850 & T1000
K924777
R.H. Burton Co.
Ophthalmic · 194d
Cleared Aug 05, 1992
CYLINDER OF GAS, CAN OF GAS (CC12F2)
K921617
Bio-Rad
Ophthalmic · 121d
Cleared Oct 15, 1991
NIDEK MODEL NT-1000
K913189
Nidek, Inc.
Ophthalmic · 89d
Cleared Jun 25, 1991
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
K911721
Keeler Instruments, Inc.
Ophthalmic · 69d
Cleared Oct 31, 1989
BIO-RAD MODULAR AIR COMPRESSOR
K895575
Bio-Rad
Ophthalmic · 47d
Cleared Jan 06, 1989
MMAC II TONOMETER
K884012
Professional Technologies Corp.
Ophthalmic · 106d
Cleared Nov 02, 1987
OBF MODEL 115 COMPUTER TONOMETER SYSTEM
K873422
Ocular Blood Flow Laboratories, Inc.
Ophthalmic · 68d
Cleared Nov 02, 1987
TONOMETER TAPES
K873917
Richmond Products, Inc.
Ophthalmic · 38d
Cleared Jun 03, 1987
T P C (TONOMETER PROBE COVER)
K871935
Krb Ent.
Ophthalmic · 15d
Cleared May 18, 1987
TOPCON COMPUTERIZED TONOMETER CT-10
K871335
Topcon Instrument Corporation of America
Ophthalmic · 45d
Cleared Mar 17, 1987
KEELER PULSAIR NON CONTACT TONOMETER
K870750
Keeler Instruments, Inc.
Ophthalmic · 20d
Cleared Feb 20, 1987
DIGILAB MICRO ONE APPLANATION TONOMETER
K870121
Bio-Rad
Ophthalmic · 39d
Cleared Feb 12, 1987
OBF MODEL 112 VACUUM CUP SYSTEM
K864959
Ocular Blood Flow Laboratories, Inc.
Ophthalmic · 56d