Omnispec ED1000
FDA 510(k) clearance K210166 · decided 2023-01-27
Clearance details
- K-number
- K210166
- Device name
- Omnispec ED1000
- Applicant
- Medispec, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-21
- Decision date
- 2023-01-27
- Days to decision
- 736 days
- Clearance type
- Traditional
- Product code
- ISA
- Device class
- 1
- Regulation number
- 890.5660
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Gaithersburg, MD, 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 |
|---|---|---|
| ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE (P040026) | Medispec, Ltd. | 2005-04-01 |
| ECONOLITH LITHOTRIPTER (P950043/S006) | Medispec, Ltd. | 1999-08-27 |
| ECONOLITH(TM) LITHOTRIPTER (P950043/S005) | Medispec, Ltd. | 1998-09-14 |
| ECONOLITH(TM) LITHOTRIPTER (P950043/S004) | Medispec, Ltd. | 1998-05-21 |
| ECONOLITH(TM) LITHOTRIPTER (P950043/S002) | Medispec, Ltd. | 1998-05-05 |
| ECONOLITH(TM) LITHOTRIPTER (P950043/S001) | Medispec, Ltd. | 1997-06-30 |
| ECONOLITH(TM) LITHOTRIPTER (P950043) | Medispec, Ltd. | 1997-04-07 |