NHancer Rx
FDA 510(k) clearance K200324 · decided 2020-08-06
Clearance details
- K-number
- K200324
- Device name
- NHancer Rx
- Applicant
- Imds Operations B.V.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-10
- Decision date
- 2020-08-06
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Roden, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.