ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6— 510(k) K092997
Substantially EquivalentEdan Instruments, Inc.
FDA 510(k) clearance K092997 for ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6, Substantially Equivalent on 2009-11-10. Applicant: Edan Instruments, Inc.. Device class: 2.
Clearance details
- Applicant
- Edan Instruments, Inc.
- Product code
- Code KNG
- Device class
- Class 2
- Regulation
- 21 CFR 884.2660
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yonkers, NY, US
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