510(k) K090499
- Device
- LIFEDOP MODEL, L350R
- Applicant
- SUMMIT DOPPLER SYSTEMS, INC.
- 510(k) number
- K090499
- Product code
- MAA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-31
- Date received
- 2009-02-25
- Regulation
- 884.2660
- Classification name
- Monitor, Fetal Doppler Ultrasound
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- KEN JARRELL
- Address
- 4680 Table Mountain Dr. #150 Golden CO US 80403 80403
FDA Registration Numbers#
- 1216677
Source Documents#
Other 510(k) Records For Product Code MAA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102138 | ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER | Edan Instruments, Inc. | 2010-10-28 |
| K915138 | GE SONOCHROME | GE Medical Systems | 1992-10-20 |
| K905536 | FETAL DOPPLER | Toshiba America Medical Systems, In.C | 1992-04-21 |
| K904600 | L582 TRANSDUCER | Acuson Corp. | 1991-06-24 |
| K905456 | L328 TRANSDUCER | Acuson Corp. | 1991-05-28 |
| K904951 | S5192R TRANSDUCER | Acuson Corp. | 1991-04-29 |
| K895909 | SONICAID MODEL VASOFLO 4 | Oxford Medilog, Inc. | 1990-07-09 |
| K894992 | QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM | Quantum Medical Systems, Inc. | 1990-02-23 |
Legacy Summary#
summary
FDA Review#
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