REDSENSE
FDA 510(k) clearance K071013 · decided 2007-10-18
Clearance details
- K-number
- K071013
- Device name
- REDSENSE
- Applicant
- Redsense Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2007-04-10
- Decision date
- 2007-10-18
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- ODX
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Findley, MN, US
- Third-party review
- No
- Expedited review
- No
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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-ALARM UNIT AND SENSOR (K103242) | Redsense Medical AB | 2011-02-10 |
| REDSENSE-HOME USE (K092955) | Redsense Medical AB | 2010-05-10 |
Recalls involving this device
No recalls on record reference this clearance.