REDSENSE ALARM SYSTEM
FDA 510(k) clearance K130554 · decided 2013-11-22
Clearance details
- K-number
- K130554
- Device name
- REDSENSE ALARM SYSTEM
- Applicant
- Redsense Medical AB
- Decision
- Substantially Equivalent
- Date received
- 2013-03-04
- Decision date
- 2013-11-22
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- ODX
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Halmstad, SE
- 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 UNIT AND SENSOR (K103242) | Redsense Medical AB | 2011-02-10 |
| 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.