FETAL ACOUSTIC STIMULATOR (FAST)
FDA premarket approval P870025/S009 · decided 2010-04-23
Approval details
- PMA number
- P870025
- Supplement
- S009
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FETAL ACOUSTIC STIMULATOR (FAST)
- Generic name
- Stimulator, fetal, acoustic
- Applicant
- Ge Medical Systems, Inc.
- Date received
- 2009-08-05
- Decision date
- 2010-04-23
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- MCP
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- APPROVAL FOR A CHANGE IN SUPPLIER OF A COIL ASSEMBLY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GE LIGHTSPEED ACT FP16 (K091673) | Ge Medical Systems, Inc. | 2009-06-24 |
| GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM (K082104) | Ge Medical Systems, Inc. | 2008-09-02 |
| GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL (K042844) | Ge Medical Systems, Inc. | 2004-11-03 |
| INNOVA 4100, INNOVA 3100 (K042053) | Ge Medical Systems, Inc. | 2004-08-26 |
| SENOGRAPHIC STEREO (K040125) | Ge Medical Systems, Inc. | 2004-04-19 |
| DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION (K033244) | Ge Medical Systems, Inc. | 2003-10-16 |
| GE 1.5T 8 CHANNEL TORSO COIL (K031209) | Ge Medical Systems, Inc. | 2003-05-23 |
| CT COLONOGRAPHY (K023943) | Ge Medical Systems, Inc. | 2003-05-06 |