DIGILAB MODULAR ONE-APPLANATION TONOMETER
FDA 510(k) clearance K863217 · decided 1986-09-24
Clearance details
- K-number
- K863217
- Device name
- DIGILAB MODULAR ONE-APPLANATION TONOMETER
- Applicant
- Bio-Rad
- Decision
- Substantially Equivalent
- Date received
- 1986-08-20
- Decision date
- 1986-09-24
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- HKX
- Device class
- 2
- Regulation number
- 886.1930
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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| VX130 Ophthalmic Diagnostic Device (K162067) | Luneau Sas | 2017-04-24 |
| VX120 Ophthalmic Diagnostic Device (K143086) | Luneau Sas | 2015-06-01 |
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| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002) | Bio-Rad | 1996-03-01 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001) | Bio-Rad | 1991-03-14 |
| BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032) | Bio-Rad | 1989-07-24 |