510(k) K080670
- Device
- MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
- Applicant
- ATCOR MEDICAL
- 510(k) number
- K080670
- Product code
- DSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-23
- Date received
- 2008-03-10
- Regulation
- 870.1110
- Classification name
- Computer, Blood-pressure
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN ABRAM
- Address
- 11/1059-1063 Victoria Rd. West Ryde Nsw AU 2114 2114
FDA Registration Numbers#
- 9710602
- 3017233611
- 2029275
- 3014541700
- 3008716327
- 3008363989
- 3010157426
- 2939520
- 1062836
- 3013783488
- 3003832357
- 3009499478
- 3004977335
- 1066270
- 3009600098
- 8020616
- 3015997711
- 1828100
- 9681377
- 3010698831
- 3013943846
- 3003800159
- 3012811961
- 3003591740
- 3013596024
- 3013500228
- 3013679558
- 9610816
- 3010703925
- 2124215
- 9710654
- 3007836437
- 3005877899
- 3008483389
- 3013826848
- 3005210579
- 3009607734
- 3008058135
- 3003589956
- 3003263092
- 3016931915
- 3008253300
- 1220908
- 3017422354
- 3007603826
- 3029871637
- 2134265
- 3010838917
- 9613067
- 3030733800
- 3003687189
- 3012359877
- 1651104
- 3033589330
- 3003971136
- 3012104670
- 3009077524
- 3016618143
- 3021559257
- 1218950
- 3005941719
- 3003647374
- 3007305624
- 3005783425
- 1527715
- 3032109181
- 3000126629
- 3005334138
- 3007621003
- 3012528160
- 3014736845
- 2183744
- 3009973336
- 3001570235
- 1000122786
- 3009156722
- 2184149
- 1058584
- 2648727
- 3004091615
Source Documents#
Other 510(k) Records For Product Code DSK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | 2023-11-03 |
| K160945 | Endophys Blood Pressure Monitor | Endophys Holdings, LLC | 2016-09-26 |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | Volcano Corporation | 2015-12-03 |
| K141615 | ENDOPHYS BLOOD PRESSURE MONITOR | Endophys, Inc. | 2015-01-07 |
| K070795 | SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM | Atcor Medical Pty, Ltd. | 2007-08-31 |
| K033738 | MONITORING SYSTEM, MODEL ARGUS PB-2200 | Schiller AG | 2004-08-24 |
| K021517 | ABP FOR WINDOWS | Rozinn Electronics, Inc. | 2002-07-24 |
| K013943 | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 | Radi Medical Systems AB | 2001-12-18 |
| K011865 | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION | Zoll Medical Corp | 2001-07-31 |
| K003122 | SMARTFLOW, MODEL SFIP 2000 | Florence Medical , Ltd. | 2001-05-14 |
| K002742 | SPHYGMOCOR MX MODEL SCOR-MX | Pwv Medical Pty, Lt. | 2001-05-01 |
| K002067 | RADIANALYZER, MODEL 12710 | Radi Medical Systems AB | 2001-01-11 |
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | 1999-12-12 |
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | Pace Tech, Inc. | 1996-11-21 |
| K943457 | AS/3 PRESSURE TEMPERATURE MODULE, M-PT | Datex Division Instrumentarium Corp. | 1994-07-27 |
Legacy Summary#
summary
FDA Review#
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