Infant Radiant Warmer - Models IW910 and IW920
FDA 510(k) K970432 · Fisher & Paykel Electronics , Ltd.
510(k) numberK970432
Submission
- Device name
- Infant Radiant Warmer - Models IW910 and IW920
- Applicant
- Fisher & Paykel Electronics , Ltd.
Auckland, NZ - Received
- February 4, 1997
- Decision date
- May 7, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Infant Radiant Warmer - Models IW910 and IW920 cleared by the FDA?
Infant Radiant Warmer - Models IW910 and IW920 (K970432) received a 510(k) decision of Substantially Equivalent on May 7, 1997, 92 days after the submission was received.
What is the product code of K970432?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.