510(k) K243727
- Device
- Re:Balans
- Applicant
- Mode Sensors AS
- 510(k) number
- K243727
- Product code
- DSB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-16
- Date received
- 2024-12-03
- Regulation
- 870.2770
- Classification name
- Plethysmograph, Impedance
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Y
Related Records
Applicant Contact
- Contact
- Magnus Nordahl
- Address
- Professor Brochs Gate 2 Trondheim NO 7030 7030
FDA Registration Numbers
- 3020885267
- 3006113127
- 3007603826
- 3012528160
- 1317188
- 9681860
- 3013596024
- 3018940143
- 3013500228
- 2015691
- 3009156722
- 3023272766
- 9610816
- 9680010
- 3006379910
- 3008716327
- 3003803088
- 3005699942
- 3005004021
- 3004782476
- 1320894
- 3043355869
- 3010849408
- 9615817
- 3008240972
- 3003971136
- 2134243
- 3016701404
- 3003832357
- 1316463
- 3009499478
- 3009077524
- 3016618143
- 3007836437
- 3014158038
- 3021559257
- 9681449
- 3008483389
- 3019130
- 3042941992
- 3004832480
- 3032916632
- 3011790297
- 3003174284
- 2025475
- 3004753774
- 3007305624
- 3003857828
- 3000130829
- 3003695829
- 2648045
- 3005783425
- 3008642652
- 3002684743
- 9610105
- 3021242837
- 3032367
- 3018783526
- 1018233
- 3000126629
- 1000610255
- 2221819
- 3037724692
- 3004987887
- 3006082230
- 2027046
- 1219324
- 2133641
- 3012044688
- 3011773282
- 3010097171
Source Documents
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| K140102 | PHYSIOFLOW Q-LINK | Vasocom, Inc. | 2014-02-12 |