510(k) K102226 ยท FMZ Incubator, Neonatal
DUAL INCU I
| Applicant | Atom Medical Corporation, Bunkyo-Ku, Tokyo, JP |
| Decision | Substantially Equivalent, Jan 4, 2011 |
| Received | Aug 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2012 | Atom Medical Corporation Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants. Terminated |
FMZ | None listed |
| Dec 1, 2011 | Atom Medical Corporation Dual Incu i (Atom Infant Incubator Model 100)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: A combination incubator and warmer for infants. Terminated |
FMZ | None listed |
| Dec 1, 2011 | Atom Medical Corporation Incu i (Atom Infant Incubator Model 101)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: An incubator for infants. Terminated |
FMZ | None listed |
| Dec 1, 2011 | Atom Medical Corporation Rabee Incu i (Atom Infant Incubator Model 102)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: An incubator for infants. Terminated |
FMZ | None listed |
| Dec 1, 2011 | Atom Medical Corporation Infa Warmer i (Atom Infant Warmer Model 103)
Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033
Usage: A warmer for infants. Terminated |
FMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.