SONDREX P.A.L. SYSTEM— 510(k) K010388
Substantially EquivalentOhmeda Medical
FDA 510(k) clearance K010388 for SONDREX P.A.L. SYSTEM, Substantially Equivalent on 2001-12-11. Applicant: Ohmeda Medical. Device class: 2.
Clearance details
- Applicant
- Ohmeda Medical
- Product code
- Code HCC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laurel, MD, US
Recent devices under product code HCC
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