SKYTRON SKYBOOM SERIES— 510(k) K950192
Substantially EquivalentSkytron, Div. the Kmw Group, Inc.
FDA 510(k) clearance K950192 for SKYTRON SKYBOOM SERIES, Substantially Equivalent on 1995-04-03. Applicant: Skytron, Div. the Kmw Group, Inc.. Device class: 1.
Clearance details
- Applicant
- Skytron, Div. the Kmw Group, Inc.
- Product code
- Code FQO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4960
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grand Rapids, MI, US
Recent devices under product code FQO
view allMore clearances from Skytron, Div. the Kmw Group, Inc.
view allAdverse events under product code FQO
product code FQO- Death
- 6
- Injury
- 145
- Malfunction
- 685
- Total
- 836
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K950192
K-number listed on FDA's recall record- Z-1569-2020 — Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1
- Z-1871-2016 — Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K950192.
Data sourced from openFDA. This site is unofficial and independent of the FDA.