Obf Model 115 Computer Tonometer System
FDA 510(k) K873422 · Ocular Blood Flow Laboratories, Inc.
510(k) numberK873422
Submission
- Device name
- Obf Model 115 Computer Tonometer System
- Applicant
- Ocular Blood Flow Laboratories, Inc.
Timonium, MD, US - Received
- August 26, 1987
- Decision date
- November 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKX – Tonometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1930
- Specialty
- Ophthalmic
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|---|---|---|---|
| K253039 | Auto Kerato-Refracto Tonometer TRK-3 OmniaHKX · Traditional | Topcon Corporation | 11/07/2025SE |
| K223739 | VS Tabletop TonometerHKX · Traditional | Medimaging Integrated Solution, Inc. | 11/08/2023SE |
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| K181260 | MiiS Horus Scope DPT 100HKX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 06/21/2019SE |
| K181143 | Keeler TonoCare TonometerHKX · Traditional | Keeler Instruments, Inc. | 02/08/2019SE |
| K180820 | Tono Vue Non-Contact TonometerHKX · Traditional | Crystalvue Medical Corporation | 12/14/2018SE |
| K162067 | VX130 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 04/24/2017SE |
| K143086 | VX120 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 06/01/2015SE |
| K113066 | Corvis STHKX · Traditional | Oculus Optikgerate GmbH | 11/08/2012SE |
| K111710 | Full Auto Tonometer Model TX-20HKX · Special | Canon Inc. -Medical Equipment Group | 09/20/2011SE |
More from Canon Inc. -Medical Equipment Group
| 510(k) | Device | Decision |
|---|---|---|
| K864959 | Obf Model 112 Vacuum Cup SystemHKX · Traditional | 02/12/1987SE |
Questions and answers
When was Obf Model 115 Computer Tonometer System cleared by the FDA?
Obf Model 115 Computer Tonometer System (K873422) received a 510(k) decision of Substantially Equivalent on November 2, 1987, 68 days after the submission was received.
What is the product code of K873422?
The FDA product code is HKX – Tonometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1930.