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510(k) Premarket Notification – Multiple Submissions (K230111, K170874, K192004, K213794, K173156)
510(k) Premarket Notification – Multiple Submissions (K230111, K170874, K192004, K213794, K173156)
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510(K) Number: K230111
Device Name: CORE 500 Digital Stethoscope
Manufacturer: Eko Devices, Inc.
Device Classification Name: Stethoscope, Electronic
Regulation Number: 870.1875
Classification Product Code: DQD
Date Received: 01/17/2023
Decision Date: 05/26/2023
Regulation Medical Specialty: Cardiovascular
Request Contents: 510(k) premarket submission notification form for K230111, K170874, K192004, K213794, K173156.
Device Name: CORE 500 Digital Stethoscope
Manufacturer: Eko Devices, Inc.
Device Classification Name: Stethoscope, Electronic
Regulation Number: 870.1875
Classification Product Code: DQD
Date Received: 01/17/2023
Decision Date: 05/26/2023
Regulation Medical Specialty: Cardiovascular
Request Contents: 510(k) premarket submission notification form for K230111, K170874, K192004, K213794, K173156.
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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