THE BAGNOLI-4 EMG SYSTEM— 510(k) K981934
Substantially EquivalentDelsys, Inc.
FDA 510(k) clearance K981934 for THE BAGNOLI-4 EMG SYSTEM, Substantially Equivalent on 1998-08-31. Applicant: Delsys, Inc.. Device class: 2.
Clearance details
- Applicant
- Delsys, Inc.
- 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
- Boston, MA, US
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