FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONDREX P.A.L. SYSTEM
K Number: K010388
·
Decision Dec 11, 2001
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
120
Review Days
306
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Basic Information
- Device Name
- SONDREX P.A.L. SYSTEM
- K Number
- K010388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ohmeda Medical
- Date Received
- February 8, 2001
- Decision Date
- December 11, 2001
- Product Code
- HCC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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| K070210 | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM | Apr 20, 2007 | Substantially Equivalent |
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| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | Apr 16, 2004 | Substantially Equivalent |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | May 9, 2002 | Substantially Equivalent |