510(k) K915285 ยท FSY Light, Surgical, Ceiling Mounted
SKYTRON INFINITY SERIES SURGICAL LIGHTS
| Applicant | Skytron, Div. the Kmw Group, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Feb 20, 1992 |
| Received | Nov 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915285
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S. Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S. Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL. Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, I Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/ Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3 Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL a Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Terminated |
FTD | None listed |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made Terminated |
FTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.