FLAATZ 600 SERIES (FLAATZ 600/601)
FDA 510(k) clearance K132842 · decided 2014-02-21
Clearance details
- K-number
- K132842
- Device name
- FLAATZ 600 SERIES (FLAATZ 600/601)
- Applicant
- Drtech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-10
- Decision date
- 2014-02-21
- Days to decision
- 164 days
- Clearance type
- Special
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seongnam-Shi, Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Drtech Corp.
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.