DOC-20010 EU MDR Sleep Diag Cannula Dec of Conf Rev 3

DECLARATION OF CONFORMITY DOC-20010 Sleep Diagnostic Cannulas

Salter Labs 30 Spur Drive El Paso, TX 79906 USA

SRN: US-MF-000007934 Basic UDI 006074TF013_SleepXcann6E

UDIs

Model Number -- Case Qty

Description

00607411500350 10607411500357 00607411500398 10607411500395 00607411500442 10607411500449 00607411500367 10607411500364 00607411500404 10607411500401 00607411500473 10607411500470 00607411500411 10607411500418 00607411500466 10607411500463 00607411801105 10607411801102

5041-7-7 5041-7-7-25 5042-7-7 5042-7-7-25 5044-7-7 5044-7-7-25 5049-7-7 5049-7-7-25 5050-7-7 5050-7-7-25 5052-7-7 5027-7-7-25 5054-7-7 5054-7-7-25 5056-7-7 5056-7-7-25 SO-1990 SO-1990-50

Adult. Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Adult. Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Adult. Oral/Nasal Pressure monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Pediatric. Nasal Pressure Monitoring Gas Sampling Cannula,7’ (2.1 m) tubes, male/female connector Pediatric. Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Pediatric. Oral/Nasal Pressure Monitoring & Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Small Pediatric. Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector Small Pediatric. Oral/Nasal Pressure Monitoring Gas Sampling Cannula, 7’ (2.1 m) tubes, male/female connector

Adult. Nasal Pressure Monitoring, 7 1/4"(0.184 m) tube, filter

Doc # FRM-10001 Rev 3

Page 3 of 3