BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR— 510(k) K031647
Substantially EquivalentGetinge USA, Inc.
FDA 510(k) clearance K031647 for BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, Substantially Equivalent on 2003-07-29. Applicant: Getinge USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Getinge USA, Inc.
- Product code
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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