| Device Type ID | 4181 |
| Device Name | Tonometer, Manual |
| Regulation Description | Tonometer And Accessories. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.1930 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HKY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 4181 |
| Device | Tonometer, Manual |
| Product Code | HKY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tonometer And Accessories. |
| CFR Regulation Number | 886.1930 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCUTOME, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICARE FINLAND OY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KEELER LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KEELER LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SENSOR MEDICAL TECHNOLOGY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TAKAGI SEIKO CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Difficult To Insert | 1 |
Loose Or Intermittent Connection | 1 |
Naturally Worn | 1 |
Device Reprocessing Problem | 1 |
Device Operates Differently Than Expected | 1 |
Contamination / Decontamination Problem | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Instrumed International, Inc. | II | Dec-16-2014 |