OptiScanner 5000 Glucose Monitoring System
FDA 510(k) clearance K162042 · decided 2017-10-16
Clearance details
- K-number
- K162042
- Device name
- OptiScanner 5000 Glucose Monitoring System
- Applicant
- Optiscan Biomedical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2016-07-25
- Decision date
- 2017-10-16
- Days to decision
- 448 days
- Clearance type
- Traditional
- Product code
- LZF
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hayward, 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 |
|---|---|---|
| OptiScanner® 5000 Glucose Monitoring System (K192785) | Optiscan Biomedical Corporation | 2020-02-05 |
| RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM (K011238) | Metracor Technologies, Inc. | 2002-01-08 |
| PUMP/BLOOD CHEMISTRY MONITOR (K951739) | Via Medical Corp. | 1996-02-28 |
| VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. (K922997) | Via Medical Corp. | 1994-01-11 |
| VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM (K920438) | Via Medical Corp. | 1993-10-22 |
| INFUSION PUMP (K882830) | Pemlab Corp. | 1988-12-30 |
Recalls involving this device
No recalls on record reference this clearance.