FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEEL SNUGGLER, MODEL 99047
K Number: K040044
·
Decision Jan 27, 2004
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
172
Review Days
15
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Basic Information
- Device Name
- HEEL SNUGGLER, MODEL 99047
- K Number
- K040044
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- January 12, 2004
- Decision Date
- January 27, 2004
- Product Code
- MPO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MPO | Infant Heel Warmer (Chemical Heat Pack) | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MPO), ordered by most recent decision date.
Infant Heel WarmerTM; Heel Snuggler®
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Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)
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Rapid Aid Instant Disposable Infant Heel Warmer
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DENOVO TEDDY GEL INFANT HEEL WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
INFANT HEEL WARMER BY INTCO
FDA 510(k)
FDA Class 1
·Physical Medicine
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
FDA 510(k)
FDA Class 1
·Physical Medicine
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