FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENOVO TEDDY GEL INFANT HEEL WARMER
K Number: K103549
·
Decision Apr 8, 2011
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
1
Review Days
126
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Basic Information
- Device Name
- DENOVO TEDDY GEL INFANT HEEL WARMER
- K Number
- K103549
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Denovo Products, LLC
- Date Received
- December 3, 2010
- Decision Date
- April 8, 2011
- Product Code
- MPO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
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 |
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