Servo-Control Wall-Mount Infant WARMER(IW980)/MANUAL-CONTROL Wall-Mount Infant WARMER(IW990)
FDA 510(k) K971461 · Fisher & Paykel Electronics , Ltd.
510(k) numberK971461
Submission
- Device name
- Servo-Control Wall-Mount Infant WARMER(IW980)/MANUAL-CONTROL Wall-Mount Infant WARMER(IW990)
- Applicant
- Fisher & Paykel Electronics , Ltd.
Auckland, NZ - Received
- April 21, 1997
- Decision date
- July 16, 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 Servo-Control Wall-Mount Infant WARMER(IW980)/MANUAL-CONTROL Wall-Mount Infant WARMER(IW990) cleared by the FDA?
Servo-Control Wall-Mount Infant WARMER(IW980)/MANUAL-CONTROL Wall-Mount Infant WARMER(IW990) (K971461) received a 510(k) decision of Substantially Equivalent on July 16, 1997, 86 days after the submission was received.
What is the product code of K971461?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.