510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Siemens Elema AB

Danvers, MA, US

Siemens Elema AB appears in FDA device records in Danvers, MA. FDA records list 63 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
63
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 63

FDA records hold 63 510(k) clearances for Siemens Elema AB between 1978 and 2003. The busiest year on record is 1984, with 19. The most recent is 2003, with 1.

Clearances by year, as a table
510(k) clearance decisions for Siemens Elema AB, by decision year
YearClearances
19781
19808
19815
19824
19832
198419
19857
19864
19875
19962
19971
20002
20011
20021
20031
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EBTISubstantially Equivalent
K010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EMHXSubstantially Equivalent
K010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407ECBKSubstantially Equivalent
K002137CATHCOR DESKTOPDQKSubstantially Equivalent
K001315MODIFICATION TO KION ANESTHESIA SYSTEMBSZSubstantially Equivalent
K970839SERVO VENTILATOR 300ACBKSubstantially Equivalent - Subject to Tracking Reg.
K960168SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990CBKSubstantially Equivalent - Subject to Tracking Reg.
K960010SERVO VENTILATOR 300 COMPUTER INTERFACECBKSubstantially Equivalent - Subject to Tracking Reg.
K872278SIEMENS O2-AIR MIXER 965BZRSubstantially Equivalent
K871354SERVO VENTILATOR 900 C/DCBKSubstantially Equivalent
K871829SIEMENS DRY AIR COMPRESSORBTISubstantially Equivalent
K871366SIEMENS MAIN FLOW BACTERIA FILTERCAHSubstantially Equivalent
K871293SERVO NEBULIZER 945 SIEMENS-ELEMA ABCAFSubstantially Equivalent
K864105LUNG MECHANICS SOFTWARE PROGRAMCBKSubstantially Equivalent
K863675CALIBRATION GAS FOR SERVO GAS MONITOR 120BXKSubstantially Equivalent
K861707MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITORCBKSubstantially Equivalent
K861625SERVO GAS MONITOR 120CCLSubstantially Equivalent
K854036MANUAL VENTILATION ACCESSORYSubstantially Equivalent
K852772GAS EVACUATION ACCESSORYCBNSubstantially Equivalent
K852771PC INTERFACECBKSubstantially Equivalent
K852601SERVO HUMIDIFIER 153BYDSubstantially Equivalent
K851044CARDIOSTAT 3 RECORDERDPSSubstantially Equivalent
K850374CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVOCBKSubstantially Equivalent
K844392CARDIOSTAT 1 ECG RECORDERDPSSubstantially Equivalent
K844912SERVO VENTILATOR 900D SIEMENS-ELEMA ABCBKSubstantially Equivalent
K841232PULSE GENERATOR 696, 696B & 696LDXYSubstantially Equivalent
K841230PULSE GENERATOR 686, 686B 686LDXYSubstantially Equivalent
K841225PULSE GENERATOR 689, 689B & 689LDXYSubstantially Equivalent
K844590POWER PACK 160 SIEMENS-ELEMA ABCBKSubstantially Equivalent
K841227BIPOLAR ENDOCARDIAL LEAD 406LDTDSubstantially Equivalent
K844040SERVO HUMIDIFIER 152 SIEMENS-ELEMA ABBYDSubstantially Equivalent
K843440MINGO LOG 7DJHSubstantially Equivalent
K841233PULSE GENERATOR 678LDXYSubstantially Equivalent
K841231PULSE GENERATOR 688B & 688LDXYSubstantially Equivalent
K841228PULSE GENERATOR 718B & 718LDXYSubstantially Equivalent
K841226PULSE GENERATOR 728, 728B & 728LDXYSubstantially Equivalent
K841229PULSE GENERATOR 698, 698B & 698LDXYSubstantially Equivalent
K841157HALOTHANE VAPORIZER 950, ENFLURANECADSubstantially Equivalent
K840326GAS SUPPLY MANIFOLD SIEMENS-ELEMA ABCAMSubstantially Equivalent
K841657PATIENT TUBING HYTREL SIEMENS-ELEMABZOSubstantially Equivalent
K841529SIEMENS-ELEMA VENTILATOR 900CCBKSubstantially Equivalent
K841393AB MANUAL VENTILATION ACCESS. 900CCBKSubstantially Equivalent
K840264SERVO CART 170BZNSubstantially Equivalent
K832898NEBULIZER ACCESSORY FOR SERVO VENTILLCAFSubstantially Equivalent
K832959PACEMAKER SYS. ANALYZER 378KRESubstantially Equivalent
K822213SIEMENS-ELEMA AB AGA REVIVATORBTMSubstantially Equivalent
K820657PULSE GENERATOR 678 BDXYSubstantially Equivalent
K820767BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60DTBSubstantially Equivalent
K813576SIEMENS-ELEMA PULSE GENERATOR 659DXYSubstantially Equivalent
K811102SIEMENS-ELEMA AB SERVO VENTILATOR 900 CCBKSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain