GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C
FDA 510(k) clearance K991629 · decided 1999-08-02
Clearance details
- K-number
- K991629
- Device name
- GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C
- Applicant
- Ge Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-11
- Decision date
- 1999-08-02
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 (P870025/S011) | Ge Medical Systems, Inc. | 2012-10-10 |
| FETAL ACOUSTIC STIMULATOR (P870025/S010) | Ge Medical Systems, Inc. | 2011-10-12 |
| FETAL ACOUSTIC STIMULATOR (FAST) (P870025/S009) | Ge Medical Systems, Inc. | 2010-04-23 |
| FETAL ACOUSTIC STIMULATOR (P870025/S008) | Ge Medical Systems, Inc. | 2006-03-02 |
| COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR (P870025/S007) | Ge Medical Systems, Inc. | 2005-03-24 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S006) | Ge Medical Systems, Inc. | 2001-11-09 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S005) | Ge Medical Systems, Inc. | 1996-07-17 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S004) | Ge Medical Systems, Inc. | 1996-02-01 |