300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER— 510(k) K874090
Substantially EquivalentMedac, Inc.
FDA 510(k) clearance K874090 for 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER, Substantially Equivalent on 1987-12-15. Applicant: Medac, Inc.. Device class: 2.
Clearance details
- Applicant
- Medac, Inc.
- 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
- Tualatin, OR, US
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