EDM— 510(k) K951369
Substantially EquivalentDeltex Medical
FDA 510(k) clearance K951369 for EDM, Substantially Equivalent on 1995-11-07. Applicant: Deltex Medical. Device class: 2.
Clearance details
- Applicant
- Deltex Medical
- Product code
- 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
- Rockville, MD, US
Recent devices under product code DPW
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