IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER— 510(k) K882138
Substantially EquivalentImex Medical Systems, Inc.
FDA 510(k) clearance K882138 for IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER, Substantially Equivalent on 1988-11-07. Applicant: Imex Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Imex Medical Systems, 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
- Golden, CO, US
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