Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)— 510(k) K151845
Substantially EquivalentCooperSurgical, Inc.
FDA 510(k) clearance K151845 for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418), Substantially Equivalent on 2016-03-18. Applicant: CooperSurgical, Inc.. Device class: 1.
Clearance details
- Applicant
- CooperSurgical, Inc.
- Product code
- Code MPO
- Device class
- Class 1
- Regulation
- 21 CFR 890.5710
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trumbull, CT, US
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