510(k) K982063 ยท FSY Light, Surgical, Ceiling Mounted
ALM PRISMALIX (PRX) SURGICAL LIGHT
| Applicant | Alm Surgical Equipment, Inc., Anaheim CA, US |
| Decision | Substantially Equivalent, Sep 22, 1998 |
| Received | Jun 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211 Open, Classified |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.