ABCOM 2000— 510(k) K912562
Substantially EquivalentApplied Biometrics, Inc.
FDA 510(k) clearance K912562 for ABCOM 2000, Substantially Equivalent on 1992-01-09. Applicant: Applied Biometrics, Inc.. Device class: 2.
Clearance details
- Applicant
- Applied Biometrics, Inc.
- Product code
- Product code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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