AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
FDA 510(k) clearance K013242 · decided 2001-12-13
Clearance details
- K-number
- K013242
- Device name
- AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2001-09-28
- Decision date
- 2001-12-13
- Days to decision
- 76 days
- Clearance type
- Abbreviated
- Product code
- FTD
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Montgomery, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 The Harmony LA/LED Monitor Arm Adap recall (Z-1886-2011) | Steris Corporation | 2011-04-05 |
| Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Har recall (Z-1218-2010) | Steris Corporation | 2010-04-01 |
| Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Har recall (Z-1219-2010) | Steris Corporation | 2010-04-01 |
| Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B12938808 recall (Z-1220-2010) | Steris Corporation | 2010-04-01 |