Company ยท US
Siemens Elema AB
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2003. Name variants (Inc, Corp, punctuation) are merged.
63510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 15 |
| DXY | Implantable Pacemaker Pulse-Generator | 15 |
| DTB | Permanent Pacemaker Electrode | 3 |
| BTI | Compressor, Air, Portable | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 2 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 |
| DPS | Electrocardiograph | 2 |
| DQK | Computer, Diagnostic, Programmable | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| BXK | Gas, Calibration (Specified Concentration) | 1 |
| BZL | Computer, Oxygen-Uptake | 1 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 |
| CAM | Yoke Assembly, Medical Gas | 1 |
| CBN | Apparatus, Gas-Scavenging | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 5, 2003 | K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E Siemens Elema AB | BTI |
| Jan 23, 2002 | K010923 | KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E Siemens Elema AB | MHX |
| Dec 18, 2001 | K010925 | SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E Siemens Elema AB | CBK |
| Oct 5, 2000 | K002137 | CATHCOR DESKTOP Siemens Elema AB | DQK |
| May 26, 2000 | K001315 | MODIFICATION TO KION ANESTHESIA SYSTEM Siemens Elema AB | BSZ |
| Oct 14, 1997 | K970839 | SERVO VENTILATOR 300A Siemens Elema AB, SE | CBK |
| Oct 25, 1996 | K960168 | SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 Siemens Elema AB | CBK |
| Oct 25, 1996 | K960010 | SERVO VENTILATOR 300 COMPUTER INTERFACE Siemens Elema AB | CBK |
| Sep 3, 1987 | K872278 | SIEMENS O2-AIR MIXER 965 Siemens Elema AB | BZR |
| Jul 21, 1987 | K871354 | SERVO VENTILATOR 900 C/D Siemens Elema AB | CBK |
| Jun 15, 1987 | K871829 | SIEMENS DRY AIR COMPRESSOR Siemens Elema AB | BTI |
| May 14, 1987 | K871366 | SIEMENS MAIN FLOW BACTERIA FILTER Siemens Elema AB | CAH |
| May 8, 1987 | K871293 | SERVO NEBULIZER 945 SIEMENS-ELEMA AB Siemens Elema AB | CAF |
| Nov 7, 1986 | K864105 | LUNG MECHANICS SOFTWARE PROGRAM Siemens Elema AB | CBK |
| Nov 3, 1986 | K863675 | CALIBRATION GAS FOR SERVO GAS MONITOR 120 Siemens Elema AB | BXK |
| Jun 19, 1986 | K861707 | MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR Siemens Elema AB | CBK |
| May 2, 1986 | K861625 | SERVO GAS MONITOR 120 Siemens Elema AB | CCL |
| Oct 23, 1985 | K854036 | MANUAL VENTILATION ACCESSORY Siemens Elema AB | |
| Oct 10, 1985 | K852772 | GAS EVACUATION ACCESSORY Siemens Elema AB | CBN |
| Oct 10, 1985 | K852771 | PC INTERFACE Siemens Elema AB | CBK |
| Jul 8, 1985 | K852601 | SERVO HUMIDIFIER 153 Siemens Elema AB | BYD |
| Jun 26, 1985 | K851044 | CARDIOSTAT 3 RECORDER Siemens Elema AB | DPS |
| Apr 25, 1985 | K850374 | CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO Siemens Elema AB | CBK |
| Apr 11, 1985 | K844392 | CARDIOSTAT 1 ECG RECORDER Siemens Elema AB | DPS |
| Dec 28, 1984 | K844912 | SERVO VENTILATOR 900D SIEMENS-ELEMA AB Siemens Elema AB | CBK |
| Dec 3, 1984 | K841232 | PULSE GENERATOR 696, 696B & 696L Siemens Elema AB | DXY |
| Dec 3, 1984 | K841230 | PULSE GENERATOR 686, 686B 686L Siemens Elema AB | DXY |
| Dec 3, 1984 | K841225 | PULSE GENERATOR 689, 689B & 689L Siemens Elema AB | DXY |
| Nov 29, 1984 | K844590 | POWER PACK 160 SIEMENS-ELEMA AB Siemens Elema AB | CBK |
| Nov 27, 1984 | K841227 | BIPOLAR ENDOCARDIAL LEAD 406L Siemens Elema AB | DTD |
| Oct 25, 1984 | K844040 | SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB Siemens Elema AB | BYD |
| Sep 4, 1984 | K843440 | MINGO LOG 7 Siemens Elema AB | DJH |
| Jul 6, 1984 | K841233 | PULSE GENERATOR 678L Siemens Elema AB | DXY |
| Jun 26, 1984 | K841231 | PULSE GENERATOR 688B & 688L Siemens Elema AB | DXY |
| Jun 26, 1984 | K841228 | PULSE GENERATOR 718B & 718L Siemens Elema AB | DXY |
| Jun 26, 1984 | K841226 | PULSE GENERATOR 728, 728B & 728L Siemens Elema AB | DXY |
| Jun 25, 1984 | K841229 | PULSE GENERATOR 698, 698B & 698L Siemens Elema AB | DXY |
| Jun 7, 1984 | K841157 | HALOTHANE VAPORIZER 950, ENFLURANE Siemens Elema AB | CAD |
| Jun 7, 1984 | K840326 | GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB Siemens Elema AB | CAM |
| May 23, 1984 | K841657 | PATIENT TUBING HYTREL SIEMENS-ELEMA Siemens Elema AB | BZO |
| May 23, 1984 | K841529 | SIEMENS-ELEMA VENTILATOR 900C Siemens Elema AB | CBK |
| May 21, 1984 | K841393 | AB MANUAL VENTILATION ACCESS. 900C Siemens Elema AB | CBK |
| Feb 4, 1984 | K840264 | SERVO CART 170 Siemens Elema AB | BZN |
| Nov 25, 1983 | K832898 | NEBULIZER ACCESSORY FOR SERVO VENTILL Siemens Elema AB | CAF |
| Nov 14, 1983 | K832959 | PACEMAKER SYS. ANALYZER 378 Siemens Elema AB | KRE |
| Oct 28, 1982 | K822213 | SIEMENS-ELEMA AB AGA REVIVATOR Siemens Elema AB | BTM |
| Apr 15, 1982 | K820657 | PULSE GENERATOR 678 B Siemens Elema AB | DXY |
| Apr 9, 1982 | K820767 | BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 Siemens Elema AB | DTB |
| Jan 22, 1982 | K813576 | SIEMENS-ELEMA PULSE GENERATOR 659 Siemens Elema AB | DXY |
| May 5, 1981 | K811102 | SIEMENS-ELEMA AB SERVO VENTILATOR 900 C Siemens Elema AB | CBK |
Newest 50 of 63.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||