ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
FDA 510(k) clearance K102138 · decided 2010-10-28
Clearance details
- K-number
- K102138
- Device name
- ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER
- Applicant
- Edan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-30
- Decision date
- 2010-10-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MAA
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIFEDOP MODEL, L350R (K090499) | Summit Doppler Systems, Inc. | 2009-03-31 |
| GE SONOCHROME (K915138) | GE Medical Systems | 1992-10-20 |
| FETAL DOPPLER (K905536) | Toshiba America Medical Systems, In.C | 1992-04-21 |
| L582 TRANSDUCER (K904600) | Acuson Corp. | 1991-06-24 |
| L328 TRANSDUCER (K905456) | Acuson Corp. | 1991-05-28 |
| S5192R TRANSDUCER (K904951) | Acuson Corp. | 1991-04-29 |
| SONICAID MODEL VASOFLO 4 (K895909) | Oxford Medilog, Inc. | 1990-07-09 |
| QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM (K894992) | Quantum Medical Systems, Inc. | 1990-02-23 |
Recalls involving this device
No recalls on record reference this clearance.