UP-GRADE AND UP-GRADE PRO
FDA 510(k) clearance K983887 · decided 1999-02-12
Clearance details
- K-number
- K983887
- Device name
- UP-GRADE AND UP-GRADE PRO
- Applicant
- Medisim, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-02
- Decision date
- 1999-02-12
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); recall (Z-0466-06) | Omron Healthcare, Inc. | 2006-02-04 |