R2 PACE PAD, MODEL 480— 510(k) K895729
Substantially EquivalentDarox Corp.
FDA 510(k) clearance K895729 for R2 PACE PAD, MODEL 480, Substantially Equivalent on 1989-10-12. Applicant: Darox Corp.. Device class: 2.
Clearance details
- Applicant
- Darox Corp.
- Product code
- Code DRO
- Device class
- Class 2
- Regulation
- 21 CFR 870.5550
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Niles, IL, US
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