ENTERSCAN
FDA 510(k) clearance K874081 · decided 1987-12-31
Clearance details
- K-number
- K874081
- Device name
- ENTERSCAN
- Applicant
- Pie Data Medical BV
- Decision
- Substantially Equivalent
- Date received
- 1987-10-07
- Decision date
- 1987-12-31
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LWI
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Maastricht 6227 Aj, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SINUSCAN 102/SINUSPRINT (K960421) | Ferguson Medical | 1997-04-16 |
| ULTRAMAX/MODEL NUMBER A1 (K960044) | Entlab OY | 1996-08-02 |
| CPR GENERAL SURGERY TRAY (K960241) | Custom Pack Reliability | 1996-03-22 |
Recalls involving this device
No recalls on record reference this clearance.