Atom Infa Warmer V-505
FDA 510(k) K002355 · Atom Medical Corp
510(k) numberK002355
Submission
- Device name
- Atom Infa Warmer V-505
- Applicant
- Atom Medical Corp
North Attleboro, MA, US - Received
- August 2, 2000
- Decision date
- October 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K102542 | Resusci Flow; Resusci Flow 104BTL · Traditional | 04/06/2011SE |
| K103828 | Bili-Therapy Spot TypeLBI · Traditional | 03/29/2011SE |
| 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 Atom Infa Warmer V-505 cleared by the FDA?
Atom Infa Warmer V-505 (K002355) received a 510(k) decision of Substantially Equivalent on October 10, 2000, 69 days after the submission was received.
What is the product code of K002355?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.