510(k) K071698 ยท FSY Light, Surgical, Ceiling Mounted
AURORA LED SERIES SURGICAL LIGHTS
| Applicant | Skytron, Div. the Kmw Group, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Jul 6, 2007 |
| Received | Jun 21, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071698
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2024 | DKK Dai-Ichi Shomei Co., Ltd. Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models).
The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. Open, Classified |
FSY | None listed |
| Aug 14, 2024 | DKK Dai-Ichi Shomei Co., Ltd. Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. Open, Classified |
FSY | None listed |
| Aug 14, 2024 | DKK Dai-Ichi Shomei Co., Ltd. Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models).
The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. Open, Classified |
FSY | None listed |
| Aug 14, 2024 | DKK Dai-Ichi Shomei Co., Ltd. Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models).
The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site. Open, Classified |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.