FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPIC BILI-BASSINET
K Number: K971601
·
Decision Sep 24, 1997
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
37
Review Days
146
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Basic Information
- Device Name
- OLYMPIC BILI-BASSINET
- K Number
- K971601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympic Medical Corp.
- Date Received
- May 1, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBI), ordered by most recent decision date.
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Infant Phototherapy Equipment
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FDA Class 2
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Neonatal Phototherapy System
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bili-hut
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neoBLUE blanket LED Phototherapy System
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Other Clearances by Olympic Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 | Jun 20, 2008 | Substantially Equivalent |
| K031149 | OLYMPIC CFM 6000 | May 14, 2003 | Substantially Equivalent |
| K020335 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 | Jun 18, 2002 | Substantially Equivalent |
| K001056 | OLYMPIC WARM-UP | Sep 29, 2000 | Substantially Equivalent |
| K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | Mar 23, 1999 | Substantially Equivalent |
| K972193 | OLYMPIX MINI-PASTEURMATIC (58210) | Sep 5, 1997 | Substantially Equivalent |
| K971117 | WARMETTE | Aug 22, 1997 | Substantially Equivalent |
| K955357 | OLYMPIC SMART SCALE MODEL 50/50RA | Jan 30, 1996 | Substantially Equivalent |
| K954434 | OLYMPIC INFANT THERMOMETER | Dec 20, 1995 | Substantially Equivalent |
| K954846 | OLYMPIC SMART SCALE | Dec 14, 1995 | Substantially Equivalent |