MMAC II TONOMETER
FDA 510(k) clearance K884012 · decided 1989-01-06
Clearance details
- K-number
- K884012
- Device name
- MMAC II TONOMETER
- Applicant
- Professional Technologies Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-22
- Decision date
- 1989-01-06
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- HKX
- Device class
- 2
- Regulation number
- 886.1930
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Redding, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (K253039) | Topcon Corporation | 2025-11-07 |
| VS Tabletop Tonometer (K223739) | Medimaging Integrated Solution, Inc. | 2023-11-08 |
| Intraocular Pressure Tonometer EASYTON (K190382) | Company Elamed | 2019-12-06 |
| MiiS Horus Scope DPT 100 (K181260) | Medimaging Integrated Solution, Inc (Miis) | 2019-06-21 |
| Keeler TonoCare Tonometer (K181143) | Keeler Instruments, Inc. | 2019-02-08 |
| Tono Vue Non-Contact Tonometer (K180820) | Crystalvue Medical Corporation | 2018-12-14 |
| VX130 Ophthalmic Diagnostic Device (K162067) | Luneau Sas | 2017-04-24 |
| VX120 Ophthalmic Diagnostic Device (K143086) | Luneau Sas | 2015-06-01 |
| CORVIS ST (K113066) | Oculus Optikgerate GmbH | 2012-11-08 |
| FULL AUTO TONOMETER MODEL TX-20 (K111710) | Canon Inc. -Medical Equipment Group | 2011-09-20 |
| PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (K093298) | Keeler Instruments, Inc. | 2010-12-10 |
| ACCUPEN (K083377) | Accutome Ultrasound, Inc. | 2009-07-27 |
Recalls involving this device
No recalls on record reference this clearance.