SKYTRON SKYBOOM SERIES
FDA 510(k) clearance K950192 · decided 1995-04-03
Clearance details
- K-number
- K950192
- Device name
- SKYTRON SKYBOOM SERIES
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-18
- Decision date
- 1995-04-03
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- FQO
- Device class
- 1
- Regulation number
- 878.4960
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor recall (Z-1871-2016) | Skytron, Div. The KMW Group, Inc | 2016-05-31 |
| Skytron General Purpose Surgical Table; Model 6600, Dist. by Skytron, Grand Rapids, MI. recall (Z-1496-06) | Skytron, Div. The KMW Group, Inc | 2006-09-13 |
| Skytron General Purpose Surgical Table, battery model; Model 6600B, Dist. by Skytron, Gran recall (Z-1497-06) | Skytron, Div. The KMW Group, Inc | 2006-09-13 |