INCU I
Incubator, Neonatal
ATOM MEDICAL CORPORATION
The following data is part of a premarket notification filed by Atom Medical Corporation with the FDA for Incu I.
Pre-market Notification Details
| Device ID | K102279 |
| 510k Number | K102279 |
| Device Name: | INCU I |
| Classification | Incubator, Neonatal |
| Applicant | ATOM MEDICAL CORPORATION 3-18-15 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Contact | Tsuyoshi Sugino |
| Correspondent | Tsuyoshi Sugino ATOM MEDICAL CORPORATION 3-18-15 HONGO Bunkyo-ku, Tokyo, JP 113-0033 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-11 |
| Decision Date | 2010-12-29 |
| Summary: | summary |
Trademark Results [INCU I]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INCU I 79095703 4097674 Live/Registered |
Atom Medical Corporation 2011-02-25 |
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