V-505 Infa Warmer
FDA 510(k) K060461 · Atom Medical, Inc.
510(k) numberK060461
Submission
- Device name
- V-505 Infa Warmer
- Applicant
- Atom Medical, Inc.
Tokoyo, Bunkyo-Ku, JP - Received
- February 22, 2006
- Decision date
- April 28, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
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| K102227 | Infa Warmer IFMT · Traditional | 01/21/2011SE |
| K102226 | Dual Incu IFMZ · Traditional | 01/04/2011SE |
| K102279 | Incu IFMZ · Traditional | 12/29/2010SE |
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Questions and answers
When was V-505 Infa Warmer cleared by the FDA?
V-505 Infa Warmer (K060461) received a 510(k) decision of Substantially Equivalent on April 28, 2006, 65 days after the submission was received.
What is the product code of K060461?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.