510(k) K130554
- Device
- REDSENSE ALARM SYSTEM
- Applicant
- REDSENSE MEDICAL AB
- 510(k) number
- K130554
- Product code
- ODX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-22
- Date received
- 2013-03-04
- Regulation
- 876.5820
- Classification name
- Autonomous Extracorporeal Blood Leak Detector/alarm
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRIK BYHMER
- Address
- Gyllenhammars Vag 26 Halmstad SE 30292 30292
FDA Registration Numbers#
- 3013791928
- 1650907
- 8030665
- 3004111573
- 3015335038
- 3006948863
- 1225714
- 9680579
Source Documents#
Other 510(k) Records For Product Code ODX #
Legacy Summary#
summary
FDA Review#
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