HAD1717MC
FDA 510(k) clearance K200018 · decided 2020-01-31
Clearance details
- K-number
- K200018
- Device name
- HAD1717MC
- Applicant
- H&Abyz
- Decision
- Substantially Equivalent
- Date received
- 2020-01-03
- Decision date
- 2020-01-31
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Yongin-Si, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch H&Abyz
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.