Product code HEP
- Device name
- Monitor, Blood-Flow, Ultrasonic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.2660
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K101960 | SONOTRAX SERIES ULTRASONIC POCKET DOPPLER | Edan Instruments, Inc. | 2010-08-10 |
| K023082 | BABYCARE | Bionet Company, Ltd. | 2003-03-03 |
| K920353 | ULTRACELL INSTRUMENT WIPE | Ultracell Medical Technologies, Inc. | 1992-09-15 |
| K910462 | POCKET DOP 3 | Imex Medical Systems, Inc. | 1991-06-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B632MDB01009 | Mediblu | MEDIBLU MEDICAL LLC | 2020-06-25 |
| B510PD100PRO1 | ADVANCED POCKET DOPPLER | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-17 |
| B510PD1000PRO1 | ADVANCED POCKET DOPPLER | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-17 |
| GYNXDB12450 | Sonotrax Basic Fetal Doppler | GYNEX CORPORATION | 2017-01-19 |
| GYNXD12500 | Sonotrax Pro Fetal Doppler | GYNEX CORPORATION | 2017-01-19 |
| 00815871020381 | E-ST | Avante | 2016-09-23 |
| 00815871020374 | E-ST | Avante | 2016-09-23 |
| 06944413800120 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413800137 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413800144 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413800151 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413800168 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413800175 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 06944413800564 | Ultrasonic Pocket Doppler | Edan Instruments, Inc. | 2016-09-01 |
| 00888937010060 | Summit Doppler | Coopersurgical, Inc. | 2016-07-21 |
| 00888937010039 | Summit Doppler | Coopersurgical, Inc. | 2016-07-21 |
| 00888937001600 | ClearTone Doppler | Coopersurgical, Inc. | 2016-07-20 |
| 00888937001556 | ClearTone Doppler | Coopersurgical, Inc. | 2016-07-20 |
| 00888937001549 | ClearTone Doppler | Coopersurgical, Inc. | 2016-07-20 |
| 00888937001501 | ClearTone Doppler | Coopersurgical, Inc. | 2016-07-20 |
| 00888937001495 | ClearTone Doppler | Coopersurgical, Inc. | 2016-07-20 |
| 00888937001310 | TRIA II Doppler | Coopersurgical, Inc. | 2016-03-31 |
| 00888937001372 | 5.0 MHz Deep Vascular Probe | Coopersurgical, Inc. | 2016-03-31 |
| 00888937001389 | 8.0 MHz Superficial Vascular Probe | Coopersurgical, Inc. | 2016-03-31 |
| 00888937001396 | 8.0 MHz Sterilizable Superficial Vascular Probe | Coopersurgical, Inc. | 2016-03-31 |
| 00888937001303 | TRIA II Display Doppler | Coopersurgical, Inc. | 2016-03-31 |
| 00888937001297 | TRIA II Display Doppler | Coopersurgical, Inc. | 2016-03-31 |
| 00888937001280 | TRIA II Doppler | Coopersurgical, Inc. | 2016-03-31 |
| 00888937001266 | TRIA II Display Doppler | Coopersurgical, Inc. | 2016-03-31 |
| 00888937001259 | TRIA II Doppler | Coopersurgical, Inc. | 2016-03-31 |