DUAL INCU I
FDA 510(k) clearance K102226 · decided 2011-01-04
Clearance details
- K-number
- K102226
- Device name
- DUAL INCU I
- Applicant
- Atom Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-08-09
- Decision date
- 2011-01-04
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- FMZ
- Device class
- 2
- Regulation number
- 880.5400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bunkyo-Ku, Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bun recall (Z-1945-2012) | Atom Medical Corporation | 2012-07-06 |
| Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunk recall (Z-0337-2012) | Atom Medical Corporation | 2011-12-01 |
| Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku recall (Z-0338-2012) | Atom Medical Corporation | 2011-12-01 |
| Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo, Bun recall (Z-0339-2012) | Atom Medical Corporation | 2011-12-01 |
| Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo, Bunky recall (Z-0340-2012) | Atom Medical Corporation | 2011-12-01 |