FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Infant Phototherapy Equipment
K Number: K210289
·
Decision May 28, 2021
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
11
Review Days
115
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Basic Information
- Device Name
- Infant Phototherapy Equipment
- K Number
- K210289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bistos Co., Ltd.
- Date Received
- February 2, 2021
- Decision Date
- May 28, 2021
- Product Code
- LBI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K160274 | Hi bebe plus | Sep 1, 2016 | Substantially Equivalent |
| K142799 | Model BT-220L and BT-220C | Jul 9, 2015 | Substantially Equivalent |
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| K121267 | BT-200V VASCULAR DOPPLER | Aug 2, 2012 | Substantially Equivalent |
| K103545 | BT-350 | May 13, 2011 | Substantially Equivalent |
| K100885 | FETAL MONITOR MODEL: BT-200T | Jun 7, 2010 | Substantially Equivalent |
| K052190 | FETAL MONITOR, MODELS BT-300 AND BT-200 | Oct 4, 2005 | Substantially Equivalent |