#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER— 510(k) K852971
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K852971 for #9431 TELETRACE, TELEPHONE, EKG TRANSMITTER, Substantially Equivalent on 1985-10-22. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- 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
- Minneapolis, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.