510(k) K083377
- Device
- ACCUPEN
- Applicant
- ACCUTOME ULTRASOUND, INC.
- 510(k) number
- K083377
- Product code
- HKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-27
- Date received
- 2008-11-14
- Regulation
- 886.1930
- Classification name
- Tonometer, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRIAN T.S. BARRETT
- Address
- 263 Great Valley Pkwy. Malvern PA US 19355 19355
FDA Registration Numbers#
- 3003617485
- 3002807715
- 1926681
- 3005324856
- 3009173773
- 3038356864
- 9612297
- 3005771344
- 3038614464
- 1319721
- 3015316279
- 3007075140
- 3003771740
- 3004443844
- 3005301392
- 9615030
- 3009496855
- 9611269
- 8030392
- 3010000450
- 3008729548
- 3004681519
- 9614661
- 3008396732
- 3010227033
- 2936921
- 9617474
- 9616199
- 3004848970
- 1000391004
- 2521877
- 3020723591
- 3004026651
- 3010069263
- 3033566
- 1000181430
- 3010287677
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | 2025-11-07 |
| K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | 2023-11-08 |
| K190382 | Intraocular Pressure Tonometer EASYTON | Company Elamed | 2019-12-06 |
| K181260 | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | 2019-06-21 |
| K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | 2019-02-08 |
| K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | 2018-12-14 |
| K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | 2017-04-24 |
| K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | 2015-06-01 |
| K113066 | CORVIS ST | Oculus Optikgerate GmbH | 2012-11-08 |
| K111710 | FULL AUTO TONOMETER MODEL TX-20 | Canon Inc. -Medical Equipment Group | 2011-09-20 |
| K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | Keeler Instruments, Inc. | 2010-12-10 |
| K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | Tomey Corporation | 2008-11-18 |
| K081756 | OCULAR RESPONSE ANALYZER | Reichert, Inc. | 2008-08-07 |
| K053444 | KOWA KT-800 | Kowa Co. , Ltd. | 2006-06-09 |
| K060780 | TONOMETER DIATON | Ryazan State Instruments | 2006-04-06 |
Legacy Summary#
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FDA Review#
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