FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUO-LITE PHOTOTHERAPY SYSTEM
K Number: K971256
·
Decision Sep 24, 1997
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
33
Review Days
173
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Basic Information
- Device Name
- DUO-LITE PHOTOTHERAPY SYSTEM
- K Number
- K971256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Air-Shields, Inc.
- Date Received
- April 4, 1997
- Decision Date
- September 24, 1997
- 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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|---|---|---|---|
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| K940975 | C450/C400 INFANT INCUBATORS | Jun 23, 1994 | Substantially Equivalent |
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| K924170 | ISOLETTE INCUBATOR HUMIDITY METER | Feb 5, 1993 | Substantially Equivalent |
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| K914864 | MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR | Mar 13, 1992 | Substantially Equivalent |