ECONOLITH(TM) LITHOTRIPTER
FDA premarket approval P950043/S002 · decided 1998-05-05
Approval details
- PMA number
- P950043
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ECONOLITH(TM) LITHOTRIPTER
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Medispec, Ltd.
- Date received
- 1998-04-06
- Decision date
- 1998-05-05
- Days to decision
- 29 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Montgomery Village, MD
- Statement
- Approval for non-synchronized ESWL, addition of a ECG simulator/adapter, and appropriate labeling revisions.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Omnispec ED1000 (K210166) | Medispec, Ltd. | 2023-01-27 |
| ECONOLITH EM1000 (K063504) | Medispec, Ltd. | 2007-03-09 |
| ECONOLITH E3000, MODEL 3000 (SW-6) (K040461) | Medispec, Ltd. | 2004-05-25 |
| LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER (K974796) | Medispec, Ltd. | 1998-03-12 |