SOFTSENS— 510(k) K001521
Substantially EquivalentIntegrated Biosensing Technologies
FDA 510(k) clearance K001521 for SOFTSENS, Substantially Equivalent on 2000-11-27. Applicant: Integrated Biosensing Technologies. Device class: 2.
Clearance details
- Applicant
- Integrated Biosensing Technologies
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waterford, CT, US
Recent devices under product code GXY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.