ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR— 510(k) K811758
Substantially EquivalentPowers Medical Systmes
FDA 510(k) clearance K811758 for ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR, Substantially Equivalent on 1981-08-03. Applicant: Powers Medical Systmes. Device class: 2.
Clearance details
- Applicant
- Powers Medical Systmes
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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