REDSENSE-ALARM UNIT AND SENSOR
FDA 510(k) clearance K103242 · decided 2011-02-10
Clearance details
- K-number
- K103242
- Device name
- REDSENSE-ALARM UNIT AND SENSOR
- Applicant
- Redsense Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2010-11-02
- Decision date
- 2011-02-10
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- ODX
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fridley, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Redsense Medical AB
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.
| Record | Firm | Date |
|---|---|---|
| REDSENSE ALARM SYSTEM (K130554) | Redsense Medical AB | 2013-11-22 |
| REDSENSE-HOME USE (K092955) | Redsense Medical AB | 2010-05-10 |
| REDSENSE (K071013) | Redsense Medical AB | 2007-10-18 |
Recalls involving this device
No recalls on record reference this clearance.