SPS-SINGLE PATIENT SYSTEM— 510(k) K821139
Substantially EquivalentExtracorporeal Medical Specialities, Inc.
FDA 510(k) clearance K821139 for SPS-SINGLE PATIENT SYSTEM, Substantially Equivalent on 1982-05-10. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.
Clearance details
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Product code
- Code FIR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- King Of Prussia, PA, US
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