FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
K Number: K840454
·
Decision Mar 23, 1984
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
33
Review Days
60
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Basic Information
- Device Name
- PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
- K Number
- K840454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Air-Shields, Inc.
- Date Received
- January 23, 1984
- Decision Date
- March 23, 1984
- Product Code
- LBI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | FDA class 2 | General Hospital |
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