ACHILLES EXPRESS ULTRASONOMETER
FDA premarket approval P970040/S003 · decided 2004-07-30
Approval details
- PMA number
- P970040
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- ACHILLES EXPRESS ULTRASONOMETER
- Generic name
- Bone sonometer
- Applicant
- Ge Lunar Corp.
- Date received
- 2004-07-15
- Decision date
- 2004-07-30
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MUA
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Madison, WI
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT GE MEDICAL SYSTEMS CHINA CO., LTD., JIANSGU, P.R. CHINA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DPX SERIES BRAVO DUO BONE DENSITOMETER (K030962) | Ge Lunar Corp. | 2003-07-25 |
| DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE (K023554) | Ge Lunar Corp. | 2002-12-20 |
| ADVANCED HIP ASSESSMENT SOFTWARE (K011917) | Ge Lunar Corp. | 2001-08-03 |