Eclipse PRO
FDA 510(k) clearance K211651 · decided 2021-11-22
Clearance details
- K-number
- K211651
- Device name
- Eclipse PRO
- Applicant
- Spacelabs Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-28
- Decision date
- 2021-11-22
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- MWJ
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hertford, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder recall (Z-0684-2025) | Spacelabs Healthcare, Ltd. | 2024-12-17 |