DOPPLER (UTD-5 & UTD-6)
FDA 510(k) clearance K771211 · decided 1977-07-14
Clearance details
- K-number
- K771211
- Device name
- DOPPLER (UTD-5 & UTD-6)
- Applicant
- Terumo America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-07-05
- Decision date
- 1977-07-14
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- HEK
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| Fetal Doppler (K142769) | Icare Newlife Technologies, Inc. | 2015-03-20 |
| ECHOHEART TRANSVAGINAL DOPPLER PROBE (K060410) | Summit Doppler Systems, Inc. | 2006-04-10 |
| FETAL PULSE DETECTOR MODEL DOP-1 (K902190) | Advanced Medical Systems, Inc. | 1990-10-22 |
| BIODOP(TM) (K883334) | Diagnosis Related Systems, Inc. | 1988-12-15 |
Recalls involving this device
No recalls on record reference this clearance.