GUARDIAN CONNECTION
FDA 510(k) clearance K101214 · decided 2010-07-23
Clearance details
- K-number
- K101214
- Device name
- GUARDIAN CONNECTION
- Applicant
- Maulin Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-04-30
- Decision date
- 2010-07-23
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FPD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Pueblo West, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Maulin Medical
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.